Biotronik GmbH & Co. KG: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Biotronik GmbH & Co. KG”, plus 1 PMA 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 |
|---|---|---|---|
| MAF | Stent, Coronary | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030037 | PMA | RITHRON-XR CORONARY STENT SYSTEM | 2005-04-29 |
Recalls
openFDA lists no recalls under a recalling firm named Biotronik GmbH & Co. KG.
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.
- Biotronik, Inc. (103 510(k)s)
- Biotronik Sales, Inc. (41 510(k)s)
- Biotronik Cardiac Pacemakers (3 510(k)s)
- Biotronik AG (1 510(k)s)
- Biotronik Nro, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotronik GmbH & Co. KG?
FDA lists 0 510(k) clearances under the applicant name “Biotronik GmbH & Co. KG”, plus 1 PMA 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 Biotronik GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are MAF (Stent, Coronary, 1).
Next steps
- See all 0 Biotronik GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code MAF, Biotronik GmbH & Co. KG'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.