Delmed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAOctober 2, 1990
K895142ENTERAL PUMP SET WITH ENTERAL SPIKEOctober 2, 1990
K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEOctober 2, 1990
K894506ENTERA-FLO ENTERAL FEEDING PUMPAugust 6, 1990
K901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONJuly 27, 1990
K901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONJuly 27, 1990
K900106CLOSED DISCONNECT SYSTEMJuly 16, 1990
K895330600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTAMay 2, 1990
K895919ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-IIIMay 2, 1990
K895246FRENTA(R) DUO-SETMay 2, 1990
K895933ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-IIIMay 2, 1990
K895696ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PUMay 2, 1990
K893209ENTERA-FLO SPIKE SETJuly 24, 1989
K893712PERITONEAL DIALYSIS SYSTEM AND ACCESS.July 24, 1989
K893231DELCLAMPJune 8, 1989
K881184INTERTECH STERILE WATER FOR INHALATIONMay 25, 1988
K872857HOSPAL DIALYSATE FOR C.A.V.H.D.October 5, 1987
K871155DELFLEX RIGID DRAIN CONTAINERJuly 16, 1987
K870626FREEDOM SET II WITH TRIFLEX VALVEJune 3, 1987
K871154DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICEApril 30, 1987