Conmedcorp: FDA filings under this applicant name
FDA lists 92 510(k) clearances under the applicant name “Conmedcorp” (first 1981, latest 2010), across 23 product codes in 6 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 43 | 43 |
| GCJ | Laparoscope, General & Plastic Surgery | 10 | 10 |
| DRX | Electrode, Electrocardiograph | 6 | 6 |
| GXY | Electrode, Cutaneous | 6 | 6 |
| CAC | Apparatus, Autotransfusion | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| GCI | Laryngoscope, Endoscope | 2 | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 |
Plus 13 more product codes.
Review panels
- General and Plastic Surgery (59)
- Cardiovascular (15)
- Neurology (6)
- Obstetrics and Gynecology (6)
- Gastroenterology and Urology (4)
- General Hospital (2)
Most recent Conmedcorp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM | GEI | 2010-11-24 | 174 |
| K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | KNT | 2006-04-28 | 15 |
| K050992 | CONMED IRRIGATION NOZZLE | KPL | 2005-07-14 | 86 |
| K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | FGE | 2005-04-22 | 25 |
| K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | OCY | 2005-03-08 | 28 |
| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | GXY | 2004-08-09 | 20 |
| K021079 | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX | GEI | 2002-07-01 | 89 |
| K021299 | CONMED HEATWAVE HAND-CONTROLLED ELETRODE | GEI | 2002-06-26 | 63 |
| K020186 | CONMED SYSTEM 5000 ESU | GEI | 2002-04-12 | 84 |
| K020135 | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 | GEI | 2002-04-12 | 87 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Conmedcorp.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Conmedcorp?
FDA lists 92 510(k) clearances under the applicant name “Conmedcorp” (first 1981, latest 2010), across 23 product codes in 6 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 Conmedcorp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conmedcorp is 82 days.
Which FDA product codes appear under Conmedcorp?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 43); GCJ (Laparoscope, General & Plastic Surgery, 10); DRX (Electrode, Electrocardiograph, 6).
Next steps
- See all 92 Conmedcorp clearances with predicates and recalls
- Run predicate analysis for product code GEI, Conmedcorp'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.