Conmed Corporation: FDA filings under this applicant name

FDA lists 83 510(k) clearances under 2 spellings of the applicant name “Conmed Corporation” (first 2004, latest 2026), plus 1 PMA decision, across 21 product codes in 7 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 82 days, against 112 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Conmed Corporation took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.

Top product codes

Plus 11 more product codes.

Review panels

• General and Plastic Surgery (36)
• Orthopedic (27)
• General Hospital (7)
• Obstetrics and Gynecology (7)
• Anesthesiology (3)
• Cardiovascular (3)
• Neurology (1)

Most recent Conmed Corporation 510(k) clearances

73 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

178 product recalls in 39 recall events; 13 initiated in the last five years. Most recent: 2026-07-14.

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.

Device clinical trials

An industry sponsor named Conmed Corporation is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:

• NCT06948591: BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures (Recruiting, started 2025-04-08)
• NCT05997381: BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (Recruiting, started 2024-01-05)

SEC filings

CONMED Corp (CNMD): EDGAR filings, CIK 816956. An SEC registrant with the same name, matched by name only.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Conmed Corporation (83)
• CONMED Corporation (1)

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 Linvatec (21 510(k)s)
• Conmed Andover Medical, Inc. (8 510(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 Corporation?

FDA lists 83 510(k) clearances under 2 spellings of the applicant name “Conmed Corporation” (first 2004, latest 2026), plus 1 PMA decision, across 21 product codes in 7 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 Corporation?

The median time from FDA receipt to decision across 510(k)s cleared under the name Conmed Corporation is 90 days. Since 2017: 82 days, versus 112 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Conmed Corporation?

The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 25); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 16); GCJ (Laparoscope, General & Plastic Surgery, 8).

Next steps

• See all 83 Conmed Corporation clearances with predicates and recalls
• Run predicate analysis for product code GEI, Conmed Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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