Company ยท US
Bioderm, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1999. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 1999 | K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING Bioderm, Inc. | KMF |
| Oct 21, 1998 | K982778 | BIODERM FOAM WOUND DRESSING Bioderm, Inc. | KMF |
| Oct 13, 1998 | K982939 | BTF THIN FILM WOUND DRESSING Bioderm, Inc. | MGP |
| Apr 9, 1998 | K980451 | BIODERM CALCIUM ALGINATE DRESSING Bioderm, Inc. | KMF |
| Dec 1, 1997 | K973429 | BIODERM FOAM WOUND DRESSING Bioderm, Inc. | KMF |
| Jan 10, 1997 | K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE Bioderm, Inc. | EXI |
| Oct 30, 1996 | K963602 | BIODERM PVP FOAM WOUND DRESSING Bioderm, Inc. | KMF |
| Jun 21, 1995 | K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING Bioderm, Inc. | NAE |
| Jun 12, 1995 | K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING Bioderm, Inc. | MGP |
| Jun 9, 1995 | K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING Bioderm, Inc. | KMF |
| Apr 25, 1995 | K950619 | BIODERM MEDICAL FOAM WOUND DRESSING Bioderm, Inc. | KMF |
| Feb 6, 1995 | K946292 | BIODERM MEDICAL COMPOSITE WOUND DRESSING Bioderm, Inc. | MGP |
| Nov 9, 1987 | K871327 | D.R.P. THREE STEP WOUND DRESSING Bioderm, Inc. | FRO |
| Feb 26, 1987 | K870352 | RUBYCELL(TM) SYNTHETIC ISLAND DRESSING Bioderm, Inc. | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2014 | BioDerm, Inc. BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes).
The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an exter Terminated |
NEC | None listed |
| Jun 10, 2014 | BioDerm, Inc. BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes).
The recalled wipes are used on intact skin for apply Terminated |
NEC | None listed |
| Jun 10, 2014 | BioDerm, Inc. BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes).
The recalled wipes are used on intact skin for applying skin prote Terminated |
NEC | None listed |