Bioderm, Inc.
Bioderm, Inc. holds FDA 510(k) medical device clearances, first cleared 1987, most recent 1999, with 3 FDA device recalls on record.
Top product codes for Bioderm, Inc.
FDA recalls by Bioderm, Inc.
- Z-1744-2014 — 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 external, non-invasive and nonsterile device.
- Z-1743-2014 — 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 applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
- Z-1742-2014 — 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 protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bioderm, Inc.
- K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING
- K982778 — BIODERM FOAM WOUND DRESSING
- K982939 — BTF THIN FILM WOUND DRESSING
- K980451 — BIODERM CALCIUM ALGINATE DRESSING
- K973429 — BIODERM FOAM WOUND DRESSING
- K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
- K963602 — BIODERM PVP FOAM WOUND DRESSING
- K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING
- K951842 — BIODERM MEDICAL TRANSPARENT FILM DRESSING
- K950685 — BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING
- K950619 — BIODERM MEDICAL FOAM WOUND DRESSING
- K946292 — BIODERM MEDICAL COMPOSITE WOUND DRESSING
- K871327 — D.R.P. THREE STEP WOUND DRESSING
- K870352 — RUBYCELL(TM) SYNTHETIC ISLAND DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.