Brahms GmbH, Part of Thermo Fisher Scientific: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Brahms GmbH, Part of Thermo Fisher Scientific”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QWH | Prognostic Test For Development Or Progression Of Preeclampsia | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220027 | De Novo | Prognostic Test For Development Or Progression Of Preeclampsia | 2023-05-18 |
Recalls
openFDA lists no recalls under a recalling firm named Brahms GmbH, Part of Thermo Fisher Scientific.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Brahms Diagnostica, LLC (6 510(k)s)
- Brahms Aktiengesellschaft (2 510(k)s)
- Brahms GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brahms GmbH, Part of Thermo Fisher Scientific?
FDA lists 0 510(k) clearances under the applicant name “Brahms GmbH, Part of Thermo Fisher Scientific”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Brahms GmbH, Part of Thermo Fisher Scientific?
The most frequent FDA product codes under this applicant name are QWH (Prognostic Test For Development Or Progression Of Preeclampsia, 1).
Next steps
- See all 0 Brahms GmbH, Part of Thermo Fisher Scientific clearances with predicates and recalls
- Run predicate analysis for product code QWH, Brahms GmbH, Part of Thermo Fisher Scientific's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.