Home / Companies / BioDerm, Inc.

BioDerm, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1744-2014Class IIBioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used onMay 31, 2011
Z-1743-2014Class IIBioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chaMay 31, 2011
Z-1742-2014Class IIBioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (ComponenMay 31, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGMay 18, 1999
K982778BIODERM FOAM WOUND DRESSINGOctober 21, 1998
K982939BTF THIN FILM WOUND DRESSINGOctober 13, 1998
K980451BIODERM CALCIUM ALGINATE DRESSINGApril 9, 1998
K973429BIODERM FOAM WOUND DRESSINGDecember 1, 1997
K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEJanuary 10, 1997
K963602BIODERM PVP FOAM WOUND DRESSINGOctober 30, 1996
K951166BIODERM MEDICAL HYDROGEL ISLAND DRESSINGJune 21, 1995
K951842BIODERM MEDICAL TRANSPARENT FILM DRESSINGJune 12, 1995
K950685BIODERM MEDICAL HYDROCOLLOID WOUND DRESSINGJune 9, 1995
K950619BIODERM MEDICAL FOAM WOUND DRESSINGApril 25, 1995
K946292BIODERM MEDICAL COMPOSITE WOUND DRESSINGFebruary 6, 1995
K871327D.R.P. THREE STEP WOUND DRESSINGNovember 9, 1987
K870352RUBYCELL(TM) SYNTHETIC ISLAND DRESSINGFebruary 26, 1987