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

77 devices

51-75 of 77

Cleared Apr 23, 1981

COBE DISPOSABLE PRESSURE TRANSDUCER

Cardiovascular · 44d

Cleared Feb 19, 1981

DIALYSATE CONCENTRATE FOR HEMODIALYSIS

Gastroenterology & Urology · 17d

Cleared Dec 22, 1980

COBE CENTRY 2 VARIABLE CONCENTRATE-18-

General & Plastic Surgery · 35d

Cleared Dec 10, 1980

DIALYSIS CONTROL UNIT-CENTRY 2000

Gastroenterology & Urology · 85d

Cleared Nov 26, 1980

COBE/STOCKERT BATTERY MODULE

Cardiovascular · 26d

Cleared Jul 28, 1980

COBE HF80, CAT. #18-580

Gastroenterology & Urology · 70d

Cleared Jul 14, 1980

COBE HEMOFLO BLOOD TUBING SETS

Gastroenterology & Urology · 55d

Cleared Apr 16, 1980

TOPICAL COOLING DEV. TCD. #27-999

Cardiovascular · 16d

Cleared Jul 03, 1979

CENTRY 2 SYSTEM #016, 103, 016, 104

Gastroenterology & Urology · 21d

Cleared May 11, 1979

FLOWMETER, OPTIFLO GAS

Cardiovascular · 52d

Cleared Mar 09, 1979

OXYGENATOR, COBE CATALOG #42-220

Cardiovascular · 15d

Cleared Dec 04, 1978

PAD, COOLING #27-999

Cardiovascular · 49d

Cleared Oct 10, 1978

PRESSURE MONITORING INJECTION LINES

Cardiovascular · 29d

Cleared Oct 05, 1978

MODIFIED STERILE DISPOSABLE STOPCOCKS

Cardiovascular · 20d

Cleared Jun 14, 1978

EXTRACORPEAL CARDIOTOMY BLOOD FILTER

Cardiovascular · 56d

Cleared Mar 02, 1978

Cardiovascular · 13d

Cleared Feb 02, 1978

BUBBLE-TYPE OXYGENATOR

Cardiovascular · 52d

Cleared Oct 04, 1977

DIALYSIS MACHINE, CENTRY II

Gastroenterology & Urology · 148d

Cleared Oct 04, 1977

Cardiovascular · 28d

Cleared Jun 14, 1977

DIALYZER, FIBER, HOLLOW

Gastroenterology & Urology · 33d

Cleared Apr 15, 1977

PARALLEL PLATE DIALYZER

Gastroenterology & Urology · 18d

Cleared Mar 07, 1977

CONSOLE, MOBILE FOR 3 PUMPS W/MASTS

Cardiovascular · 63d

Cleared Mar 07, 1977

STOPCOCK, ONE WAY

Gastroenterology & Urology · 7d

Cleared Nov 19, 1976

FITTING/DIALYZER

General & Plastic Surgery · 38d

Cleared Oct 21, 1976

FISTULA NEEDLE (#11-265)

Gastroenterology & Urology · 34d

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