Extracorporeal Medical Specialities, Inc. - FDA 510(k) Cleared Devices
69
Total
69
Cleared
0
Denied
69 devices
Cleared
Jul 08, 1982
HANCOCK VASCULAR GRAFT
Cardiovascular
126d
Cleared
Jun 02, 1982
INTERPULSE MEMBRANE OXYGENATOR
Cardiovascular
36d
Cleared
May 10, 1982
TS-180 SERIES TUBING SET
Gastroenterology & Urology
19d
Cleared
May 10, 1982
SPS-SINGLE PATIENT SYSTEM
Gastroenterology & Urology
19d
Cleared
Feb 05, 1982
MALE LUER CONNECTOR & HINGED CAP
Gastroenterology & Urology
15d
Cleared
Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
Cardiovascular
76d
Cleared
Nov 16, 1981
EXTRASENSR ULTRAFILTRATION MONITOR
Gastroenterology & Urology
129d
Cleared
Jun 23, 1981
MODEL DM-333 DIALYSIS CONTROL STATION
Gastroenterology & Urology
32d
Cleared
Jun 12, 1981
EXP 200 PARALLEL PLATE DIALYZER
Gastroenterology & Urology
21d
Cleared
Jun 12, 1981
EXP 600 PARALLEL PLATE DIALYZER
Gastroenterology & Urology
21d
Cleared
Jun 02, 1981
PARALLEL PLATE DIALYZER HOLDER
Gastroenterology & Urology
22d
Cleared
Jan 29, 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
Gastroenterology & Urology
122d
Cleared
Jan 22, 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
Cardiovascular
57d
Cleared
Dec 22, 1980
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
Cardiovascular
19d
Cleared
Dec 17, 1980
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
Gastroenterology & Urology
30d
Cleared
Nov 25, 1980
ARTERIOVENOUS BLOOD TUBING SETS
Gastroenterology & Urology
8d
Cleared
Jul 21, 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
Gastroenterology & Urology
46d
Cleared
May 20, 1980
MOD. DM-356 IPS INTERFACE MODULE
Gastroenterology & Urology
43d
Cleared
May 14, 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
Gastroenterology & Urology
37d
Cleared
Apr 10, 1980
MODEL TRIEX-L HOLLOW FIBER DIALYZER
Gastroenterology & Urology
31d
Cleared
Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
20d
Cleared
Feb 21, 1980
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
Cardiovascular
24d
Cleared
Nov 16, 1979
MODELS DM-360 & DM-350-L SINGLE PATIENT
Gastroenterology & Urology
18d
Cleared
Nov 16, 1979
MODEL DM 353 & DM-353-L SINGLE NEEDLE
Gastroenterology & Urology
18d
Cleared
Nov 13, 1979
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
Gastroenterology & Urology
43d