Conmed Andover Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Conmed Andover Medical, Inc.” (first 1994, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CONMED, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 6 | 6 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Cardiovascular (7)
- Neurology (1)
Most recent Conmed Andover Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945836 | 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES | DRX | 1995-06-20 | 203 |
| K946273 | 1700 MONITORING ECG ELECTRODE | DRX | 1995-05-17 | 146 |
| K944726 | 1710 MONITORING ECG ELECTRODE | DRX | 1994-11-22 | 57 |
| K944655 | ECG ELECTRODE | DRX | 1994-11-22 | 62 |
| K944849 | 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE | DRX | 1994-10-17 | 17 |
| K942718 | CLOTH TENS/BNES ELECTRODE | GXY | 1994-09-22 | 105 |
| K941839 | DISPOSABLE SURGICAL CABLE | DSA | 1994-07-27 | 105 |
| K942925 | CONMED ANDOVER MED ECG ELECTRODES | DRX | 1994-07-20 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Conmed Andover Medical, Inc..
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.
- Conmed Corporation (83 510(k)s)
- Conmed Linvatec (21 510(k)s)
- Conmed Integrated Systems (Cmis) (5 510(k)s)
- Conmed Endoscopic Technologies, Inc. (2 510(k)s)
- Conmed Corporation, Largo (1 510(k)s)
- Conmed Electrosurgery (1 510(k)s)
- Conmed Integrated Systems, Canada, Ulc (1 510(k)s)
- Conmed Linvatec Biomaterials (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Conmed Andover Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Conmed Andover Medical, Inc.” (first 1994, latest 1995), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Conmed Andover Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conmed Andover Medical, Inc. is 84 days.
Which FDA product codes appear under Conmed Andover Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 6); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 8 Conmed Andover Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Conmed Andover Medical, Inc.'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.