Medical Device Manufacturer · US , Mchenry , IL

Howmedica Corp. - FDA 510(k) Cleared Devices

373 submissions · 325 cleared · Since 1976

Recent clearances: MICRO DYNAMIC MESH, TYPE 3 FEMORAL COMPONENTS, DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION

373

Total

325

Cleared

0

Denied

FDA 510(k) Regulatory Record - Howmedica Corp. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Jul 29, 1985

P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION

Cardiovascular · 17d

Cleared Jul 19, 1985

HOMEDICA CEMENTED ACETABULAR COMPONENT 6262

Cardiovascular · 94d

Cleared Jan 28, 1983

AUFRANC-TURNER ATS METAL BACKED ACETABU

Cardiovascular · 17d

Cleared Mar 02, 1982

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH

Cardiovascular · 29d

Cleared Sep 16, 1980

DEKNATEL GOOSEN VASCULAR PUNCH BLADES

Cardiovascular · 19d