Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list BioDerm with 14 510(k) clearances and 3 device recalls. The most recent is a device recall dated May 31, 2011: BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral co….
| Date | Record | Source |
|---|---|---|
| May 31, 2011 | BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wiClass II · On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External ma | Device recalls |
| May 31, 2011 | BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectanClass II · On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm | Device recalls |
| May 31, 2011 | BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The Class II · On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External ma | Device recalls |
| May 18, 1999 | MODIFICATION OF:BIODERM FOAM WOUND DRESSINGK990955 · KMF | 510(k) clearances |
| Oct 21, 1998 | BIODERM FOAM WOUND DRESSINGK982778 · KMF | 510(k) clearances |
| Oct 13, 1998 | BTF THIN FILM WOUND DRESSINGK982939 · MGP | 510(k) clearances |
| Apr 9, 1998 | BIODERM CALCIUM ALGINATE DRESSINGK980451 · KMF | 510(k) clearances |
| Dec 1, 1997 | BIODERM FOAM WOUND DRESSINGK973429 · KMF | 510(k) clearances |
| Jan 10, 1997 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEK963950 · EXI | 510(k) clearances |
| Oct 30, 1996 | BIODERM PVP FOAM WOUND DRESSINGK963602 · KMF | 510(k) clearances |
| Jun 21, 1995 | BIODERM MEDICAL HYDROGEL ISLAND DRESSINGK951166 · NAE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
