Medical Device Manufacturer · US , Mchenry , IL

Olympus Corp. - FDA 510(k) Cleared Devices

142 submissions · 140 cleared · Since 1978

Official Website

142

Total

140

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Dec 27, 1991

OLYMPUS RETRACTABLE VALVULOTOME

Cardiovascular · 255d

Cleared Jul 17, 1991

OLYMPUS AF ANGIOSCOPE SYSTEM

Cardiovascular · 114d

Cleared Jun 03, 1991

OLYMPUS ANGIOSCOPY IRRIGATION SHEATH

Cardiovascular · 89d

Cleared Jan 02, 1990

OLYMPUS VALVULOTOME W/DETACHABLE TIP

Cardiovascular · 89d

Cleared Oct 12, 1989

OLYMPUS VALVULOTOME W/FIXED TIP

Cardiovascular · 85d

Cleared Jan 10, 1989

ANGIOPUMP TUBING SET

Cardiovascular · 89d

Cleared Feb 29, 1988

OLYMPUS ANGIOSCOPY SHEATH

Cardiovascular · 206d

Cleared Nov 30, 1987

OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE

Cardiovascular · 224d

Cleared Nov 20, 1986

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE

Cardiovascular · 258d