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. Gastroenterology & Urology ✕

32 devices

1-12 of 32

Cleared Mar 22, 1991

COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC

Gastroenterology & Urology · 437d

Cleared Feb 12, 1991

COBE CENTRY 2 BICART OPTION KIT

Gastroenterology & Urology · 47d

Cleared Feb 11, 1991

COBE CENTRYSYSTEM 3 BICART OPTION KIT

Gastroenterology & Urology · 73d

Cleared Dec 12, 1990

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER

Gastroenterology & Urology · 64d

Cleared Oct 18, 1989

COBE 2991 SUPPLEMENTARY DISPOSABLE SETS

Gastroenterology & Urology · 138d

Cleared Sep 15, 1988

COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS

Gastroenterology & Urology · 140d

Cleared Apr 21, 1988

CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002

Gastroenterology & Urology · 38d

Cleared Mar 27, 1987

COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS

Gastroenterology & Urology · 108d

Cleared Oct 17, 1985

COBE REN NEW-D DISPENSING KIT

Gastroenterology & Urology · 35d

Cleared Jun 12, 1985

Gastroenterology & Urology · 72d

Cleared Apr 20, 1984

CENTRY 2000 DIALYSIS CONTROL UNIT

Gastroenterology & Urology · 65d

Cleared Apr 06, 1983

Gastroenterology & Urology · 36d