Extracorporeal Medical Specialities, Inc. - FDA 510(k) Cleared Devices
69
Total
69
Cleared
0
Denied
FDA 510(k) Regulatory Record - Extracorporeal Medical Specialities, Inc. Gastroenterology & Urology ✕
49 devices
Cleared
May 30, 1984
HEMOPERFUSION SYSTEM TP-400
Gastroenterology & Urology
119d
Cleared
Feb 04, 1984
EXP* 500 PARALLEL PLATE DIALYZER
Gastroenterology & Urology
26d
Cleared
Feb 04, 1984
EXP* 700 PARALLEL PLATE DIALYZER
Gastroenterology & Urology
22d
Cleared
Jan 03, 1984
THERAPEUTIC EXCHANGE SYSTEM
Gastroenterology & Urology
245d
Cleared
Jan 03, 1984
ULTRAFILTRATION CONTROLLER
Gastroenterology & Urology
155d
Cleared
Oct 14, 1983
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
Gastroenterology & Urology
164d
Cleared
Sep 29, 1983
SINGLE PATIENT SYS. II MODEL DM-450
Gastroenterology & Urology
94d
Cleared
Aug 26, 1983
HEMOPERFUSION SYSTEM TP-400
Gastroenterology & Urology
149d
Cleared
Jun 08, 1983
BICARBONATE/VARIABLE SODIUM KIT-DM-367
Gastroenterology & Urology
79d
Cleared
Jun 02, 1983
EXTRASENSR ULTRAFILTRATION MONITOR
Gastroenterology & Urology
29d
Cleared
Feb 16, 1983
KF-101-07 DIALYZER
Gastroenterology & Urology
196d
Cleared
Feb 16, 1983
KF-101-10 DIALYZER
Gastroenterology & Urology
196d
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