Brennen Medical, Inc.
St. Paul, MN, US
Brennen Medical, Inc. appears in FDA device records in St. Paul, MN. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Brennen Medical, Inc. between 1994 and 2012. The busiest year on record is 2000, with 4. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 2 |
| 1998 | 3 |
| 2000 | 4 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113866 | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX | KGN | Substantially Equivalent | |
| K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | FTM | Substantially Equivalent | |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | FTM | Substantially Equivalent | |
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | FRO | Substantially Equivalent | |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | PAG | Substantially Equivalent | |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | FTL | Substantially Equivalent | |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | MGQ | Substantially Equivalent | |
| K002077 | GLUCANPRO CREAM | MGQ | Substantially Equivalent | |
| K000519 | GLUCANPRO | MGQ | Substantially Equivalent | |
| K000518 | MACROPRO GEL | MGQ | Substantially Equivalent | |
| K982825 | BRENNEN MEDICAL BETA GLUCAN GEL | MGQ | Substantially Equivalent | |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | PAG | Substantially Equivalent | |
| K980962 | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO | MGQ | Substantially Equivalent | |
| K964241 | BRENNEN MEDICAL GLUCAN II WOUND DRESSING | MGQ | Substantially Equivalent | |
| K963128 | NOVAGEL SILICONE GEL SHEETING | MDA | Substantially Equivalent | |
| K950032 | MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING | KGN | Substantially Equivalent | |
| K950281 | MESH MATRIX WOUND DRESSING | KGN | Substantially Equivalent | |
| K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING | KGN | Substantially Equivalent for Some Indications | |
| K941125 | NOVAGEL SILICONE GEL SHEETING | MDA | Substantially Equivalent | |
| K935060 | BRENNEN MEDICAL STERILE SALINE SOLUTION | KMF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KMFBandage, Liquid
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- FRODressing, Wound, Drug
- MDAElastomer, Silicone, For Scar Management
- FTMMesh, Surgical
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- FTLMesh, Surgical, Polymeric
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
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 Brennen Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Brennen Medical, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain