inforMED
FEI 3004491689

Conmed Corporation

6363 S Fiddlers Green Cir Ste 1400, Greenwood Village, CO, US

MDR events3,110All time
Recalls177All time
Registered products35
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

35 product codes

Recent MDR events

3,110 on file

Recalls

177 on file

Compliance history

Matched by FEI 3004491689.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Apr 6, 2026

    Compliance: Devices · Citations posted

  • Voluntary Action Indicated (VAI)Apr 6, 2026

    Postmarket Assurance: Devices · Citations posted

Inspection citations

6 on file

Top cited requirements

Compare to industry ↗
  • 21 CFR 806.10(a)(2)Apr 6, 2026

    Report of violation of the Act (see 803.52(e)(9))

  • 21 CFR 830.310(b)Apr 6, 2026

    GUDID Information required for unique device identification.

  • ISO 13485:2016 Clause 7.3.1Apr 6, 2026

    Design and development procedures not documented

  • ISO 13485:2016 Clause 7.3.9Apr 6, 2026

    Procedures to control design and development changes not documented

  • ISO 13485:2016 Clause 8.2.2Apr 6, 2026

    Complaint handling procedures lack required elements

  • ISO 13485:2016 Clause 8.5.2Apr 6, 2026

    Corrective action procedures not documented

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.