Medical Device Manufacturer · US , Mchenry , IL

Cobe Laboratories, Inc. - FDA 510(k) Cleared Devices

77 submissions · 77 cleared · Since 1976

Official Website

77

Total

77

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cobe Laboratories, Inc. Cardiovascular ✕

37 devices

1-12 of 37

Cleared May 11, 1993

COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR

Cardiovascular · 309d

Cleared Dec 17, 1990

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

Cardiovascular · 196d

Cleared Dec 17, 1990

COBE ICU CONVERSION KIT

Cardiovascular · 186d

Cleared May 22, 1990

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

Cardiovascular · 84d

Cleared May 17, 1990

HEPARINIZED ARTERIAL SCREEN BLOOD FILTER

Cardiovascular · 90d

Cleared Nov 03, 1989

Cardiovascular · 81d

Cleared Jun 10, 1988

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

Cardiovascular · 73d

Cleared Apr 01, 1988

Cardiovascular · 87d

Cleared May 06, 1987

ONGUARD 1000, CATALOG #043611-000 & 043611-001

Cardiovascular · 57d

Cleared Sep 15, 1986

VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN

Cardiovascular · 129d

Cleared Jul 18, 1986

COBE ACCESSORY INTERFACE MODULE (AIM)

Cardiovascular · 65d

Cleared Feb 26, 1986

SWANK ARTERIAL LINE BLOOD FILTER HF6000

Cardiovascular · 70d

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