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Universal Medical Instrument Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K962180CATH SEALNovember 7, 1996
K935077CATH-SEALJune 7, 1994
K897128UMI BRAIDED CATHETER CONNECTORMarch 1, 1990
K881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEJuly 26, 1988
K863178UMI STEERABLE TORQUE GUIDE WIRESeptember 19, 1986
K861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTROAugust 5, 1986
K860168UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLEFebruary 19, 1986
K851088UMI ANGIOGRAPHIC CATHETERMay 16, 1985
K850820PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SIDApril 10, 1985
K844558UMI AMNIOCENTESIS KIT W/SPINAL NEEDLEJanuary 31, 1985
K842259PCI W/CATH-SEAL SIDE FLOW FITTINGAugust 1, 1984
K842012UMI CURVED CHEMONUCLEOLYSIS NEEDLEJuly 6, 1984
K834436CHEMONUCLEOLYSIS NEEDLEMarch 15, 1984
K833937UMI PERCUTANEOUS TRANSHEPATIC CHOLANJanuary 3, 1984
K832193NICE PACKAugust 31, 1983
K830019AMNIO CENTESES KIT W/NEEDLEJanuary 18, 1983
K822586TEFLON COATED GUIDE WIRES & CATHETEROctober 18, 1982
K822290STERILE PROTECTIVE SLEEVE W/TOUGH-BORSTAugust 31, 1982
K822247CATH-SEALAugust 19, 1982
K812999PET POLYETHYLENE TORQUE CATHETERNovember 16, 1981