Smith & Nephew United, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
34
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGOctober 25, 1996
K961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITJuly 16, 1996
K945330ALLEVYN ADHESIVEFebruary 9, 1995
K943619CAVI-CARE CONFORMING FOAM DRESSINGAugust 19, 1994
K942748INTRASITEJune 29, 1994
K935705ALLEVYN ISLAND WOUND DRESSINGFebruary 15, 1994
K935803CICA-CARE SILICONE GEL SHEETFebruary 3, 1994
K932263SOLOSITE DERMAL WOUND GELOctober 1, 1993
K926508INTRASITE GELJuly 13, 1993
K922897STRAPPALSeptember 15, 1992
K914147ALLEVLYN WOUND DRESSING, MODIFICATIONFebruary 3, 1992
K915150REMOVE ADHESIVE REMOVERJanuary 9, 1992
K911682AIRSTRIP FIRST AID & POST-OP DRESSINGJuly 17, 1991
K911660INTRASITE HYDROCOLLOID WOUND DRESSINGJune 17, 1991
K904411INTRASITE GEL (LABELING REVISION)November 26, 1990
K904412ALLEVYN DRESSING CLAIMS CHANGEOctober 23, 1990
K901876INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)June 28, 1990
K901877ALLEVYN DRESSING (LABELING REVISED)June 22, 1990
K901879INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)June 22, 1990
K901878INTRASITE GEL (LABELING REVISION)June 22, 1990