Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
32 devices
Cleared
Sep 24, 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
Gastroenterology & Urology
48d
Cleared
Oct 25, 1988
REDY 2000
Gastroenterology & Urology
134d
Cleared
Jun 28, 1988
NEPHROSS I.Q. ALLEGO
Gastroenterology & Urology
33d
Cleared
Jun 28, 1988
NEPHROSS I.Q. MODERATO
Gastroenterology & Urology
33d
Cleared
Jun 28, 1988
BIO*NEPHROSS I.Q. ANDANTE
Gastroenterology & Urology
22d
Cleared
Jan 29, 1988
NEPHROSS I.Q. ANDANTE
Gastroenterology & Urology
86d
Cleared
Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
Gastroenterology & Urology
79d
Cleared
Jun 26, 1986
FAST FORMALERT
Gastroenterology & Urology
304d
Cleared
Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
Gastroenterology & Urology
48d
Cleared
Nov 08, 1985
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
Gastroenterology & Urology
32d
Cleared
Nov 05, 1985
ASA BLOOD TUBING LINES
Gastroenterology & Urology
13d
Cleared
Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
Gastroenterology & Urology
15d