Medical Device Manufacturer · US , Mchenry , IL

Extracorporeal Medical Specialities, Inc. - FDA 510(k) Cleared Devices

69 submissions · 69 cleared · Since 1976
69
Total
69
Cleared
0
Denied
49 devices
26-49 of 49
Cleared Jun 02, 1981
PARALLEL PLATE DIALYZER HOLDER
K811292 · FKI
Gastroenterology & Urology · 22d
Cleared Jan 29, 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
K802364 · FJG
Gastroenterology & Urology · 122d
Cleared Dec 17, 1980
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880 · FKP
Gastroenterology & Urology · 30d
Cleared Nov 25, 1980
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · FJK
Gastroenterology & Urology · 8d
Cleared Jul 21, 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
K801344 · FJI
Gastroenterology & Urology · 46d
Cleared May 20, 1980
MOD. DM-356 IPS INTERFACE MODULE
K800771 · FKQ
Gastroenterology & Urology · 43d
Cleared May 14, 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
K800772 · FKR
Gastroenterology & Urology · 37d
Cleared Apr 10, 1980
MODEL TRIEX-L HOLLOW FIBER DIALYZER
K800549 · FJI
Gastroenterology & Urology · 31d
Cleared Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270 · FJI
Gastroenterology & Urology · 20d
Cleared Nov 16, 1979
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173 · FKP
Gastroenterology & Urology · 18d
Cleared Nov 16, 1979
MODEL DM 353 & DM-353-L SINGLE NEEDLE
K792174 · FIF
Gastroenterology & Urology · 18d
Cleared Nov 13, 1979
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961 · FJG
Gastroenterology & Urology · 43d
Cleared Nov 05, 1979
HOLLOW FIBER DIALIZER MODEL TRIEX-3
K791857
Gastroenterology & Urology · 47d
Cleared Jun 27, 1979
INTEGRATED PATIENT STATIONS
K790902
Gastroenterology & Urology · 48d
Cleared Apr 20, 1979
ARTERIOVENOUS SETS
K790381 · KOC
Gastroenterology & Urology · 52d
Cleared Dec 07, 1978
ULTRAFILTRATION SCALE
K781633 · FIL
Gastroenterology & Urology · 77d
Cleared Sep 07, 1978
PATIENT AID, MODEL DM-351
K781176 · FKQ
Gastroenterology & Urology · 57d
Cleared Aug 31, 1978
TEST MODULE MODEL DM-352
K781215
Gastroenterology & Urology · 45d
Cleared Jun 22, 1978
SINGLE PATIENT SYSTEMS
K780682 · FKP
Gastroenterology & Urology · 59d
Cleared Jun 14, 1978
ARTERIOVENOUS BLOOD TUBING SETS
K780681 · FJK
Gastroenterology & Urology · 51d
Cleared Nov 28, 1977
DIALYSIS MACHINES DM-346 & 346-1
K772163 · FIJ
Gastroenterology & Urology · 12d
Cleared Mar 30, 1977
MEMBRANE SOURCE-EX SERIES DIALYZER CART.
K770516 · KNX
Gastroenterology & Urology · 12d
Cleared Jan 10, 1977
ARTERIOVENOUS BLOOD TUBING SETS
K761326 · FJK
Gastroenterology & Urology · 14d
Cleared Dec 06, 1976
TRIEX-1 HOLLOW FIBER DIALYZER
K760781 · FJT
Gastroenterology & Urology · 62d
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