Extracorporeal Medical Specialities, Inc. - FDA 510(k) Cleared Devices
69
Total
69
Cleared
0
Denied
49 devices
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
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
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
Cleared
Nov 05, 1979
HOLLOW FIBER DIALIZER MODEL TRIEX-3
Gastroenterology & Urology
47d
Cleared
Jun 27, 1979
INTEGRATED PATIENT STATIONS
Gastroenterology & Urology
48d
Cleared
Apr 20, 1979
ARTERIOVENOUS SETS
Gastroenterology & Urology
52d
Cleared
Dec 07, 1978
ULTRAFILTRATION SCALE
Gastroenterology & Urology
77d
Cleared
Sep 07, 1978
PATIENT AID, MODEL DM-351
Gastroenterology & Urology
57d
Cleared
Aug 31, 1978
TEST MODULE MODEL DM-352
Gastroenterology & Urology
45d
Cleared
Jun 22, 1978
SINGLE PATIENT SYSTEMS
Gastroenterology & Urology
59d
Cleared
Jun 14, 1978
ARTERIOVENOUS BLOOD TUBING SETS
Gastroenterology & Urology
51d
Cleared
Nov 28, 1977
DIALYSIS MACHINES DM-346 & 346-1
Gastroenterology & Urology
12d
Cleared
Mar 30, 1977
MEMBRANE SOURCE-EX SERIES DIALYZER CART.
Gastroenterology & Urology
12d
Cleared
Jan 10, 1977
ARTERIOVENOUS BLOOD TUBING SETS
Gastroenterology & Urology
14d
Cleared
Dec 06, 1976
TRIEX-1 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
62d