Bioderm, Inc.
Wheaton, IL, US
Bioderm, Inc. appears in FDA device records in Wheaton, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Bioderm, Inc. between 1987 and 1999. The busiest year on record is 1995, with 5. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING | KMF | Substantially Equivalent | |
| K982778 | BIODERM FOAM WOUND DRESSING | KMF | Substantially Equivalent | |
| K982939 | BTF THIN FILM WOUND DRESSING | MGP | Substantially Equivalent | |
| K980451 | BIODERM CALCIUM ALGINATE DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K973429 | BIODERM FOAM WOUND DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | EXI | Substantially Equivalent | |
| K963602 | BIODERM PVP FOAM WOUND DRESSING | KMF | Substantially Equivalent | |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | NAE | Substantially Equivalent | |
| K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING | MGP | Substantially Equivalent | |
| K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING | KMF | Substantially Equivalent | |
| K950619 | BIODERM MEDICAL FOAM WOUND DRESSING | KMF | Substantially Equivalent | |
| K946292 | BIODERM MEDICAL COMPOSITE WOUND DRESSING | MGP | Substantially Equivalent | |
| K871327 | D.R.P. THREE STEP WOUND DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K870352 | RUBYCELL(TM) SYNTHETIC ISLAND DRESSING | FRO | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers. | Class II | Terminated | |
| 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. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. | Class II | Terminated | |
| 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. | On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Bioderm, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain