Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
130 devices
Cleared
Nov 05, 1985
ASA BLOOD TUBING LINES
Gastroenterology & Urology
13d
Cleared
Oct 25, 1985
NML TSH IRMA
Chemistry
18d
Cleared
Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
Gastroenterology & Urology
15d
Cleared
Apr 12, 1985
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
Gastroenterology & Urology
43d
Cleared
Mar 12, 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
Gastroenterology & Urology
105d
Cleared
Mar 12, 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
Gastroenterology & Urology
28d
Cleared
Jan 22, 1985
NEPHROSS ALLEGRO H.F.
Gastroenterology & Urology
47d
Cleared
Nov 16, 1984
ASN MONITOR SINGLE NEEDLE MONITOR
Gastroenterology & Urology
70d
Cleared
Sep 12, 1984
HEMOPERFUSION PROCEDURE W/REDY 2000
Gastroenterology & Urology
78d
Cleared
Aug 27, 1984
FLUID WARMER
Gastroenterology & Urology
77d
Cleared
Aug 02, 1984
ASCORBIC ACID
Gastroenterology & Urology
59d
Cleared
Jul 31, 1984
PACKETS FOR THE PREP OF DIALYSATES &
Gastroenterology & Urology
62d
Cleared
Mar 22, 1984
BSM 2000 DIALYSIS MACHINE
Gastroenterology & Urology
73d
Cleared
Feb 06, 1984
REDY 2000
Gastroenterology & Urology
Cleared
Oct 14, 1983
NEPHROSS PRESTO
Gastroenterology & Urology
66d
Cleared
Aug 11, 1983
READER MICROELISA SYSTEM
Chemistry
80d
Cleared
Aug 08, 1983
WASHER 6000 MICRO-C LISA SYSTEM
Chemistry
77d
Cleared
Aug 01, 1983
PIPETTE 12 CHANNEL
Chemistry
70d
Cleared
Jul 26, 1983
HEATING BLOCK MICROELISA SYSTEM
Chemistry
64d
Cleared
Jul 26, 1983
STRIPREADER MICROELISA SYSTEM
Chemistry
64d
Cleared
Jul 26, 1983
MICROELISA COMP
Chemistry
64d
Cleared
Dec 07, 1982
NEPHROSS, ANDANTE H.F.
Gastroenterology & Urology
25d
Cleared
Mar 23, 1982
SORB II
Gastroenterology & Urology
90d
Cleared
Dec 08, 1981
D-3260 SORBENT CARTRIDGE
Gastroenterology & Urology
55d
Cleared
Jul 31, 1981
D-3160 SORBENT CARTRIDGE
Gastroenterology & Urology
94d
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