[REAL-RECORD SAMPLE — Public FDA Records — Educational Use]
This is a real-record sample of the TrueMedDevice US Public Regulatory Status Snapshot. It is anchored on a real, publicly registered Class II medical device family from a long-established US-active manufacturer (B. Braun Medical Inc. — Volumetric Infusion Pump). Every source URL in this sample links to the live FDA database where the reader can verify each claim independently.
Methodology note. Specific record-level fields marked
live search returns […]reflect the result the reader gets by clicking the cited search URL and entering the stated search keys. The structural identifiers stated as facts (FDA product code FRN, regulation 21 CFR 880.5725, device class II, manufacturer name B. Braun Medical Inc.) are derived from public regulation (the FDA Product Classification database) and FDA registration records that have been stable for many years. The report-preparation date below is the as-of date for every search; live results may evolve. No specific 510(k) number, FEI, recall number, MAUDE event count, or warning letter is fabricated. Every searchable claim cites a clickable FDA URL the reader can use to view the live current state.Educational use only. This sample is published as an illustration of the report format. It is not a compliance, legal, import, purchasing, or safety conclusion about B. Braun Medical Inc. or its products. Inclusion of B. Braun Medical Inc. as the worked example reflects the company's long-standing public FDA presence and its position as one of several major US-active infusion pump manufacturers — not a comment on the company's quality, compliance posture, or product safety.
Service boundary. Public-data-based research and review support — not a regulatory, legal, import, purchasing, or compliance decision. Final decisions remain with the buyer's qualified RA/QA, regulatory, legal, or procurement professional.
US Public Regulatory Status Snapshot — Volumetric Infusion Pump / B. Braun Medical Inc.
| Cover field | Value |
|---|---|
| Report ID | STATUS-US-REAL-SAMPLE-2026-0001 |
| Jurisdiction | United States |
| Product searched | Volumetric Infusion Pump (general device family — see §1) |
| Manufacturer searched | B. Braun Medical Inc. (US subsidiary of B. Braun SE; long-established US-active medical device manufacturer) |
| Report issued | 2026-04-26 (this is the as-of date for every live search cited below) |
| Search scope | FDA public databases (Product Classification, 510(k), PMA, De Novo, Establishment Registration, Recalls, Enforcement, Warning Letters, MAUDE adverse events, Safety Communications, Import Alerts, Import Refusals); 24-month window for post-market signals |
| Buyer reference | Educational sample — no buyer order |
Per-source as-of date table
| Source | As-of (report-prep date) | How the date is set |
|---|---|---|
| FDA Product Classification database | 2026-04-26 | Live search URL clicked on this date |
| FDA 510(k) database | 2026-04-26 | Live search URL clicked on this date |
| FDA PMA database | 2026-04-26 | Live search URL clicked on this date |
| FDA De Novo database | 2026-04-26 | Live search URL clicked on this date (manual lookup) |
| FDA Establishment Registration & Listing | 2026-04-26 | Live search URL clicked on this date |
| FDA Recalls (CDRH) | 2026-04-26 | Live search URL clicked on this date |
| FDA Enforcement Reports (openFDA) | 2026-04-26 | Live search URL clicked on this date |
| FDA Warning Letters | 2026-04-26 | Live search URL clicked on this date (manual lookup) |
| FDA MAUDE adverse events | 2026-04-26 | Live search URL clicked on this date |
| FDA Safety Communications | 2026-04-26 | Live search URL clicked on this date |
| FDA Import Alerts / Import Refusals | 2026-04-26 | Live search URL clicked on this date (manual lookup) |
Executive Snapshot
| Public clearance / authorization indicators | The FDA Product Classification database confirms product code FRN ("Pump, Infusion") under regulation 21 CFR 880.5725, Device Class II — this is a public, stable regulatory classification that has been in place for many years. Live search of the FDA 510(k) database for applicant B. Braun Medical Inc. (and historical applicant variants) returns multiple historical 510(k) clearances under product code FRN — see §2 row 2. |
| Establishment indicators | Live search of FDA Establishment Registration & Listing for B. Braun Medical Inc. returns active US registration record(s) with FRN among the listed product codes — see §2 row 5. |
| Recall / enforcement signals (24-month window) | Live search of FDA recall and enforcement databases for B. Braun Medical Inc. + product code FRN (window 2024-04-26 to 2026-04-25) — see §2 row 6 / row 7. The buyer's RA/QA professional clicks the cited URL to view the live current list. TrueMedDevice does not interpret whether any recall surfaced indicates a safety, compliance, or quality concern. |
| MAUDE adverse-event signal (24-month window) | Live search of FDA MAUDE for manufacturer B. Braun + product code FRN (window 2024-04-26 to 2026-04-25) — see §2 row 9. MAUDE is voluntary reporting and is known to under-represent actual event frequency. Counts are a public-data signal, not an absolute measure. |
| Safety communications | Live search of FDA Safety Communications for B. Braun + relevant terms — see §2 row 10. |
| Import alerts / refusals | Manual lookup of FDA Import Alerts and Import Refusals for B. Braun Medical Inc. — see §2 row 11. |
| Matching confidence | L4 — Strong product / manufacturer / model match (per the TrueMedDevice Matching Confidence framework). Buyer-supplied product code FRN was directly verified against the FDA Product Classification database; manufacturer name B. Braun Medical Inc. was matched against FDA Establishment Registration & Listing with one note about the broader corporate family (B. Braun SE / B. Braun Medical Inc. — see §16). |
| Red flags for professional review | The general infusion pump device class (FRN) has a multi-decade history of public recall and MAUDE activity across many manufacturers. The buyer's RA/QA professional should review the live search results for the specific 24-month window and adapt them to the buyer's specific configuration / lot / decision context — see §17 questions 8 and 9. |
Plain-English summary (3 sentences): TrueMedDevice confirmed that B. Braun Medical Inc. is a publicly registered manufacturer at the FDA, with active US establishment registration listing FRN ("Pump, Infusion", Class II, 21 CFR 880.5725) among its product codes, and with multiple historical 510(k) clearances under that product code (verifiable at the cited search URLs). The 24-month live searches for recalls, enforcement, warning letters, MAUDE events, and import alerts can be replicated by clicking the cited URLs in §2; the analyst's task in a paid order is to summarize the live results and call out items the buyer's RA/QA professional should review. This snapshot is a public-record check, not a compliance, legal, import, purchasing, or regulatory decision.
§1 — Identification & search keys used
So the buyer can replicate the search and the buyer's RA/QA professional can verify scope:
| Search key (verbatim) | Source(s) used against |
|---|---|
Product family: Volumetric Infusion Pump |
Conceptual anchor; mapped to product code FRN via FDA Product Classification database |
Manufacturer: B. Braun Medical Inc. (with one corporate-family note about parent B. Braun SE — see §16 Matching Notes) |
FDA 510(k) applicant; FDA Establishment Registration registrant; FDA Enforcement / Recall recalling firm; FDA MAUDE manufacturer field; FDA Warning Letters search; FDA Import Alerts and Refusals search |
FDA product code: FRN (Pump, Infusion — Class II, 21 CFR 880.5725 — verified against FDA Product Classification database, §2 row 1) |
FDA 510(k); FDA Recall; FDA MAUDE; FDA Enforcement |
| 510(k) number supplied by buyer: (none — sample is product-family-level) | n/a |
| PMA number supplied by buyer: (none) | FDA PMA — search by manufacturer + product code only |
| De Novo number supplied by buyer: (none) | FDA De Novo — manual search by manufacturer + device name |
| Date window for post-market signals | 2024-04-26 to 2026-04-25 (24 months) |
| Jurisdictions in scope | United States only (Health Canada is a separate $199 SKU) |
The buyer's RA/QA professional can re-run any of the searches above by visiting the source databases in the Source Appendix (§19) and entering the same search keys.
§2 — Source results table
Every "live search returns" cell is a verifiable claim — clicking the source URL and entering the search key reproduces the result. Specific record-level identifiers (K-numbers, FEI numbers, recall numbers, MAUDE event totals) are not asserted in this educational sample; instead the cited search URL is the authoritative live source. A paid TrueMedDevice Status Snapshot cites the specific identifiers selected by the analyst at delivery time, with each identifier traceable to the same live search URL.
| # | Source | Search key | Result | Source URL | As-of | Limitation note |
|---|---|---|---|---|---|---|
| 1 | FDA Product Classification | product code FRN |
Confirmed. Product code FRN = "Pump, Infusion" — Device Class II — regulation 21 CFR 880.5725 — FDA-recognized product code under the device classification framework. (This is a stable public regulatory classification.) | FDA Product Classification — search code FRN | 2026-04-26 | Reference data; updates approximately weekly. |
| 2 | FDA 510(k) | applicant: B. Braun Medical Inc.; product code FRN |
Live search returns multiple cleared 510(k)s for B. Braun Medical Inc. under product code FRN (and adjacent infusion-related codes). The buyer's RA/QA professional opens the search URL, applies the search keys, and reviews the listed clearances. For a paid order, the analyst selects the most-likely match for the buyer's specific product / model and cites the specific K-number, applicant, decision date, and device-name-as-published-by-FDA. | FDA 510(k) Premarket Notification database — search by applicant name and/or product code | 2026-04-26 | Live search URL; daily refresh on FDA's side. The number of historical clearances under one applicant + product code can be substantial; selection of the most-relevant clearance for a buyer's specific product is part of the analyst's task in a paid order. |
| 3 | FDA PMA | applicant: B. Braun Medical Inc.; product code FRN |
No record surfaced in FDA PMA database for B. Braun Medical Inc. + product code FRN as of 2026-04-26. This is consistent with FRN being a Class II 510(k) device family — PMA is the FDA pathway for Class III devices and most products under FRN do not have PMA records. |
FDA PMA database — search by applicant + product code | 2026-04-26 | Negative result; absence of evidence is not evidence of absence — see §14b What This Does NOT Mean |
| 4 | FDA De Novo | applicant: B. Braun Medical Inc.; device family infusion pump |
No record surfaced in FDA De Novo database for B. Braun Medical Inc. + infusion pump as of 2026-04-26. Most products with a 510(k) clearance do not have a De Novo classification record; De Novo is the pathway for novel devices without a predicate. |
FDA De Novo database — manual search | 2026-04-26 (manual lookup) | Manual lookup; the date above is the analyst's lookup date, not the source's last-publication date |
| 5 | FDA Establishment Registration & Listing | name: B. Braun Medical Inc.; product code FRN |
Live search returns active US establishment registration(s) for B. Braun Medical Inc. with FRN among the listed product codes. The buyer's RA/QA professional opens the search URL, applies the search keys, and reviews the listed registration record(s) (FEI, registered legal name, listed product codes, registered address). For a paid order, the analyst cites the specific registration record relevant to the buyer's product. | FDA Establishment Registration & Listing — search by name | 2026-04-26 | Reference data; updates approximately weekly. Some manufacturers register under a parent or subsidiary entity — see §16 Matching Notes for B. Braun's corporate-family note. |
| 6 | FDA Recalls (CDRH) | recalling firm: B. Braun Medical Inc.; product code FRN; window 2024-04-26 to 2026-04-25 |
Live search returns the current list of FDA CDRH recalls matching the search keys in the 24-month window. The buyer's RA/QA professional opens the search URL, applies the search keys, and reviews the listed records (recall number, classification, posted date, product description, status). For a paid order, the analyst lists each recall in scope with full citation. TrueMedDevice does not interpret whether any recall surfaced indicates a safety or compliance concern. | FDA CDRH Recall database — search by recalling firm and product code | 2026-04-26 | FDA enforcement reports may be added retroactively; absence in this window is not a guarantee of absence overall. The medical-device infusion pump category has a multi-decade public recall history across many manufacturers. |
| 7 | FDA Enforcement Reports (openFDA) | recalling firm: B. Braun Medical Inc.; product code FRN; window 2024-04-26 to 2026-04-25 |
Live API endpoint returns the current list of FDA enforcement reports matching the search keys. Programmatic access; the buyer's RA/QA professional or analyst can use the openFDA endpoint as a verification cross-check against §2 row 6. | openFDA Device Enforcement endpoint | 2026-04-26 | Cross-check of row 6; deduplicated by recall_number. |
| 8 | FDA Warning Letters | company name: B. Braun Medical Inc. |
Manual search at the FDA Warning Letters portal for B. Braun Medical Inc. as of 2026-04-26. The portal supports filtering by company name. The buyer's RA/QA professional opens the URL and applies the search; the analyst at paid-order time cites any letter found. |
FDA Warning Letters portal — search by company name | 2026-04-26 (manual lookup) | Manual lookup; FDA may issue letters that are not yet posted publicly; manufacturers may operate under multiple legal entity names — confirm registered legal name |
| 9 | FDA MAUDE adverse events | manufacturer: B. Braun; product code FRN; window 2024-04-26 to 2026-04-25 |
Live MAUDE search returns the current count and listing of adverse-event reports matching the search keys in the 24-month window. The buyer's RA/QA professional opens the search URL, applies the search keys, and reviews the count and severity distribution as posted (death / serious injury / malfunction / other) and the top problem-code clusters in MAUDE's own taxonomy. No verbatim MAUDE narratives quoted in this sample. | FDA MAUDE search — search by manufacturer + product code | 2026-04-26 | MAUDE is voluntary reporting and is known to under-represent actual event frequency. Counts are a public-data signal, not an absolute measure. Severity distribution is reported as posted, not as adjudicated. |
| 10 | FDA Safety Communications | search terms: B. Braun + infusion pump, last 24 months |
Live search of the FDA Safety Communications archive for the search terms. The buyer's RA/QA professional opens the search URL and reviews any communications listed. | FDA Safety Communications archive | 2026-04-26 | Archive is searchable by keyword; FDA may post communications retroactively |
| 11 | FDA Import Alerts / Import Refusals | company name: B. Braun Medical Inc. |
Manual search at FDA Import Alerts (IA list) and FDA Import Refusals as of 2026-04-26. The buyer's RA/QA professional opens both URLs and applies the search; the analyst at paid-order time cites any matching item. | FDA Import Alerts and FDA Import Refusals — manual searches by company name | 2026-04-26 (manual lookup) | Manual lookups; manufacturer may operate under additional importer-of-record names not searched here. |
§16 — Matching notes
Overall matching confidence: L4 — Strong product / manufacturer / model match.
Rationale:
- Product code
FRNwas directly verified against the FDA Product Classification database (§2 row 1). This is the strongest single match signal, since product code is the primary key the FDA uses to organize device records. The classification record is stable public regulatory data, not a search-time observation. - Manufacturer name
B. Braun Medical Inc.was matched against the FDA Establishment Registration & Listing database (§2 row 5). One corporate-family note is appropriate: B. Braun Medical Inc. is the US subsidiary of B. Braun SE (German parent corporation). FDA records are filed under the US legal entity name; the buyer's RA/QA professional should be aware that a buyer dealing with B. Braun materials sourced through other channels (e.g., a German-side legal entity) may see a different applicant / registrant name in non-US records. For a paid order, the analyst confirms the registered legal name in the matched FDA record matches the entity the buyer is sourcing from. - No buyer-supplied 510(k) number was provided in this educational sample, so direct K-number resolution (which would push the level toward L5) was not attempted. A paid order with a buyer-supplied K-number that resolves directly to a record under the same applicant + product code typically produces L5.
What L4 means in this report: the buyer-supplied identifiers (manufacturer + product code) corroborate each other and resolve to a coherent set of public records via live searches that the buyer can re-run. The match is high-confidence based on FDA's own classification scheme, but the Matching Confidence framework remains a measure of how reliably we matched the buyer's input to the public record — not a measure of the device's quality, the manufacturer's quality, or the buyer's transaction.
If the buyer's specific model / configuration / manufacturing-site differs from a clearance cited in the live search results, the match level may need to be revised — see §17 question 4.
§13 — What was found
- A confirmed FDA product code for the device family — FRN, Class II, regulation 21 CFR 880.5725 (§2 row 1).
- Multiple historical 510(k) clearances for the manufacturer under that product code, retrievable by the cited search URL (§2 row 2).
- Active FDA establishment registration for the manufacturer with FRN among listed product codes, retrievable by the cited search URL (§2 row 5).
- Live recall / enforcement / MAUDE / safety-communication / warning-letter / import-alert search results for the manufacturer + product code, retrievable by the cited URLs (§2 rows 6-11). The analyst at paid-order time summarizes specific records found.
§14 — What was not found
- No FDA PMA approval record under the manufacturer + product code combination (§2 row 3) — consistent with FRN being a Class II 510(k) device family.
- No FDA De Novo classification record for the manufacturer + device family (§2 row 4) — consistent with the device family being on the 510(k) pathway.
Important — what "not found" means here: the analyst searched the named source databases on the as-of date with the keys listed in §1, and no record matched. It does not mean the event did not occur. Public databases lag actual events; warning letters are sometimes posted after issuance; manufacturers may operate under additional legal entity names that the search did not cover. See §14b What This Does NOT Mean below.
§14b — What this does NOT mean
- It does not mean the device "is compliant," "is approved," or "is safe to import / purchase / source." This snapshot is a public-record check, not a compliance, legal, import, purchasing, or regulatory decision.
- It does not mean the absence of warning letters / safety communications / import alerts in the search results represents an absence of regulatory issues. Public databases can lag; some actions are not posted publicly until after a publication delay; some are recorded under different legal entity names; some are FOIA-only.
- It does not mean any recall surfaced in the live search at §2 row 6 / row 7 covers the specific configuration, lot, or model the buyer is sourcing. Recalls are scoped to specific product / lot / serial ranges — confirm with the manufacturer per §17 question 8.
- It does not mean any MAUDE event count surfaced in the live search at §2 row 9 tells you whether the device is safe. MAUDE is voluntary reporting under-representing actual event frequency; counts are a public-data signal, not an adjudicated measure of safety.
- It does not mean the inclusion of B. Braun Medical Inc. as the worked example in this sample is a comment on the company's quality, compliance posture, or product safety. The company was selected for its long-standing public FDA presence and its position as one of several major US-active infusion pump manufacturers — the sample is a format illustration, not a recommendation or critique.
- It does not mean TrueMedDevice has independently verified anything beyond the public-record citations shown. Final decisions on classification, pathway, registration, recall response, CAPA disposition, import action, purchasing, or any other regulatory or commercial action remain with the buyer's qualified RA/QA, regulatory, legal, or procurement professional.
§15 — Recommended next checks
Suggestions for the buyer's RA/QA, regulatory, legal, or procurement professional review. These are starting suggestions; the professional adapts them to the specific decision context.
- "Open each cited FDA URL in the Source Appendix and review the live current results — the snapshot is the analyst's organized view as of 2026-04-26; live records may have evolved."
- "For a buyer-specific 510(k) match, identify the 510(k) number from the search results that corresponds most closely to the specific product / model being sourced — substantial equivalence is scoped to the specific cleared device, and product-line evolution can mean a current model differs from the cleared device."
- "For any recall surfaced in the live search at §2 row 6, review whether the recall covers the specific lot / serial range and decision context. Recalls are scoped to specific products / lots."
- "Review the MAUDE problem-code clusters identified in the live search at §2 row 9. The clusters indicate which failure modes have been reported publicly; the RA/QA professional may wish to map these against the buyer's own complaint or PMS process."
- "For sourcing decisions, ISO 13485 certification status is held by the manufacturer separately from FDA registration and is typically requested directly — see §17 question 10."
§17 — Recommended Next Questions for the supplier / manufacturer / RA-QA
Questions the buyer can put to the supplier, manufacturer, or RA/QA professional after reading this report. Public identifiers and publicly-shareable documents only — no confidential design info or trade secrets requested.
About product identification:
- "Can you provide the exact FDA 510(k) number for the specific model / configuration we are sourcing?"
- "Can you confirm the FDA product code under which this product is currently registered (we expect FRN for a volumetric infusion pump under 21 CFR 880.5725; please confirm)?"
- "Can you confirm the manufacturer legal entity (e.g.,
B. Braun Medical Inc.for US-channel sourcing) exactly matches the entity listed on the FDA establishment registration we located in our public-record search?" - "Can you confirm the model / catalog number on the label exactly matches the model in the most relevant 510(k) record under the search results above?"
- "Has the product name, model number, or any identifier changed from the version listed in the FDA public record? If yes, when?"
About product documentation:
- "Can you provide the current product labeling, IFU (instructions for use), and UDI/DI?"
- "Can you provide the manufacturer product page URL or the current brochure for this specific configuration?"
About post-market history:
- "Can you provide a manufacturer-issued statement of any recall, correction, removal, or field safety notice history for this specific model in the United States (over the period relevant to our decision)? For any FDA recall surfaced in the live search at §2 row 6, does it cover the specific lot / serial range we are sourcing?"
- "For any FDA recall, enforcement action, warning letter, or safety signal surfaced in the live searches above, can you explain the public action — what was the determined root cause, and what corrective action was implemented?"
About quality system documentation:
- "Can you provide the manufacturer's ISO 13485 certificate (or equivalent QMS certification) and confirm the scope of certification covers the specific product?"
- "Can you provide the FDA Establishment Registration / FEI documentation for the manufacturing site? Does the manufacturing site for our specific order match the registered site we located in the live search at §2 row 5?"
About distribution / responsibility:
- "Who is the responsible importer / distributor / authorized representative in the United States for this product, and is that party also covered by the establishment registration?"
- "Can the manufacturer or distributor confirm whether the same product is sold under any other trade names or private labels?"
The supplier's, manufacturer's, or RA/QA professional's answers to these questions are not verified by TrueMedDevice. The buyer's qualified RA/QA, regulatory, legal, or procurement professional should independently assess any supplier-provided information.
§19 — Source appendix
All source URLs cited in this report. Every URL is a real, stable FDA database surface — clicking each verifies the corresponding row of §2. No FDA logo or endorsement implied; URLs are listed as text citations.
| # | Source | URL | What we used it for |
|---|---|---|---|
| A | FDA Product Classification database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm |
§2 row 1 — confirm FRN code, regulation 21 CFR 880.5725, device class II |
| B | FDA 510(k) Premarket Notification database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm |
§2 row 2 — search by applicant + product code; review historical clearances |
| C | FDA PMA database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm |
§2 row 3 — confirm no PMA record under product code / manufacturer |
| D | FDA De Novo database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm |
§2 row 4 — manual search by manufacturer + device name |
| E | FDA Establishment Registration & Listing | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm |
§2 row 5 — search by registrant name; verify FEI; confirm listed product codes |
| F | FDA CDRH Recall records (RES) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm |
§2 row 6 — search by recalling firm + product code |
| G | openFDA Device Enforcement endpoint | https://api.fda.gov/device/enforcement.json |
§2 row 7 — programmatic verification of recall record |
| H | FDA Warning Letters portal | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters |
§2 row 8 — manual search by company name |
| I | FDA MAUDE Adverse Event Reports search | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm |
§2 row 9 — search by manufacturer + product code |
| J | FDA Safety Communications archive | https://www.fda.gov/medical-devices/medical-device-safety/safety-communications |
§2 row 10 — search safety-communications archive |
| K | FDA Import Alerts (IA list) | https://www.accessdata.fda.gov/cms_ia/iaList.html |
§2 row 11 — manual search for import alerts naming the manufacturer |
| L | FDA Import Refusals search | https://www.accessdata.fda.gov/scripts/importrefusals/ |
§2 row 11 — manual search for import refusals naming the manufacturer |
§20 — Limitations and disclaimer
Per-source limitations (also stated inline at each source row in §2):
- MAUDE is voluntary reporting and is known to under-represent actual event frequency. Severity distribution is reported as posted, not as adjudicated.
- FDA recall publication can be retroactive. A recall not surfaced in this report's 24-month window may exist outside the window or may be added later.
- FDA Warning Letters are searched manually at the date noted; FDA may issue letters that are not yet posted publicly.
- FDA Import Alerts and Import Refusals are manually searched at the date noted; manufacturer may operate under additional legal-entity names not captured by this search.
- FDA Establishment Registration & Listing is updated approximately weekly; very recent registrations or changes may not yet appear.
- All searches are jurisdiction-scoped to the United States. Health Canada, EU MDR, UKCA, AU TGA, and other jurisdictions are not in scope of this snapshot.
- The medical-device infusion pump device class (product code FRN) has a multi-decade public recall and MAUDE history across many manufacturers. Any signals surfaced in the live searches in §2 are normal post-market public-record artifacts; the buyer's RA/QA professional contextualizes them against the buyer's specific product / configuration / decision.
"Absence of evidence is not evidence of absence." A "no records surfaced" result in this report means the search keys, sources, and date window listed in §1 did not return matching records on the as-of date — it does not mean the event did not occur or that no record exists outside the search scope.
Scope of the worked example. B. Braun Medical Inc. was selected as the worked manufacturer in this educational sample because of its long-standing public FDA presence and its position as one of several major US-active infusion pump manufacturers. No claim is made or implied about B. Braun Medical Inc.'s product safety, compliance posture, regulatory status, or any decision the buyer might make about purchasing, importing, distributing, or sourcing its products. This sample illustrates the report format only.
Service boundary (verbatim, mandatory on every page footer in the final PDF):
Public-data-based research and review support — not a regulatory, legal, import, purchasing, or compliance decision. Final decisions remain with the buyer's qualified RA/QA, regulatory, legal, or procurement professional.
[REAL-RECORD SAMPLE — Public FDA Records — Educational Use] Every source URL above links to the live FDA database. The structural identifiers (product code FRN, regulation 21 CFR 880.5725, device class II, manufacturer name B. Braun Medical Inc.) are stable public regulatory facts. Specific record-level identifiers cited at the live-search URLs reflect the FDA's current state at the time the buyer or analyst clicks the URL. In a paid TrueMedDevice US Status Snapshot, the analyst captures the live results, selects the most-relevant records for the buyer's specific product / decision context, and cites each by its specific FDA-assigned identifier.