Medical Device Manufacturer · US , Research Triangle Pa , NC

Linvatec Corp. - FDA 510(k) Cleared Devices

93 submissions · 87 cleared · Since 1992

93

Total

87

Cleared

0

Denied

FDA 510(k) Regulatory Record - Linvatec Corp. Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Jul 20, 1998

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY

Ear, Nose, Throat · 73d

Cleared Jan 17, 1997

APEX UNIVERSAL DRIVE SYSTEM

Ear, Nose, Throat · 65d

Cleared Apr 26, 1996

IRRIGATION SYSTEM

Ear, Nose, Throat · 31d

Cleared Apr 17, 1995

INTRAARC DRIVE SYSTEM

Ear, Nose, Throat · 27d

Cleared Nov 18, 1994

APEX UNIVERSAL DRIVE SYSTEM

Ear, Nose, Throat · 67d