BioDerm, Inc.
FDA Regulatory Profile
BioDerm, Inc. appears in FDA public data with 3 recalls, 14 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1744-2014, Class II) was initiated on May 31, 2011. Its most recent 510(k) clearance was granted on May 18, 1999.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 14
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1744-2014 | Class II | BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on | May 31, 2011 |
| Z-1743-2014 | Class II | BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection cha | May 31, 2011 |
| Z-1742-2014 | Class II | BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Componen | May 31, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING | May 18, 1999 |
| K982778 | BIODERM FOAM WOUND DRESSING | October 21, 1998 |
| K982939 | BTF THIN FILM WOUND DRESSING | October 13, 1998 |
| K980451 | BIODERM CALCIUM ALGINATE DRESSING | April 9, 1998 |
| K973429 | BIODERM FOAM WOUND DRESSING | December 1, 1997 |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | January 10, 1997 |
| K963602 | BIODERM PVP FOAM WOUND DRESSING | October 30, 1996 |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | June 21, 1995 |
| K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING | June 12, 1995 |
| K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING | June 9, 1995 |
| K950619 | BIODERM MEDICAL FOAM WOUND DRESSING | April 25, 1995 |
| K946292 | BIODERM MEDICAL COMPOSITE WOUND DRESSING | February 6, 1995 |
| K871327 | D.R.P. THREE STEP WOUND DRESSING | November 9, 1987 |
| K870352 | RUBYCELL(TM) SYNTHETIC ISLAND DRESSING | February 26, 1987 |