Medical Device Manufacturer · US

Delmed, Inc. - FDA 510(k) Cleared Devices

27 submissions · 26 cleared · Since 1979
27
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Delmed, Inc. Gastroenterology & Urology
20 devices
1-20 of 20
Cleared Oct 02, 1990
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · KNT
Gastroenterology & Urology · 412d
Cleared Oct 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · KNT
Gastroenterology & Urology · 397d
Cleared Oct 02, 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · KNT
Gastroenterology & Urology · 377d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · FKX
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478 · FKX
Gastroenterology & Urology · 122d
Cleared Jul 16, 1990
CLOSED DISCONNECT SYSTEM
K900106 · KDJ
Gastroenterology & Urology · 188d
Cleared May 02, 1990
FRENTA(R) DUO-SET
K895246 · KNT
Gastroenterology & Urology · 254d
Cleared May 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
K895330 · KNT
Gastroenterology & Urology · 244d
Cleared May 02, 1990
ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
K895696 · KNT
Gastroenterology & Urology · 223d
Cleared May 02, 1990
ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
K895919 · KNT
Gastroenterology & Urology · 204d
Cleared May 02, 1990
ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
K895933 · KNT
Gastroenterology & Urology · 204d
Cleared Jul 24, 1989
ENTERA-FLO SPIKE SET
K893209 · KNT
Gastroenterology & Urology · 88d
Cleared Jul 24, 1989
PERITONEAL DIALYSIS SYSTEM AND ACCESS.
K893712 · KDJ
Gastroenterology & Urology · 67d
Cleared Jun 08, 1989
DELCLAMP
K893231 · KDJ
Gastroenterology & Urology · 41d
Cleared Oct 05, 1987
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · KPO
Gastroenterology & Urology · 76d
Cleared Jul 16, 1987
DELFLEX RIGID DRAIN CONTAINER
K871155 · KDJ
Gastroenterology & Urology · 114d
Cleared Jun 03, 1987
FREEDOM SET II WITH TRIFLEX VALVE
K870626 · KDJ
Gastroenterology & Urology · 110d
Cleared Apr 30, 1987
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
K871154 · KDJ
Gastroenterology & Urology · 37d
Cleared Aug 11, 1983
EMPTY DIALYSATE CONTAINER
K831689 · FKK
Gastroenterology & Urology · 79d
Cleared Mar 29, 1983
EMPTY DIALYSATE CONTAINER BB-69
K830689 · FKX
Gastroenterology & Urology · 42d
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