Company ยท US
Brennen Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2012. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 7 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 4 |
| FTM | Mesh, Surgical | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 |
| FRO | Dressing, Wound, Drug | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| KMF | Bandage, Liquid | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 2012 | K113866 | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX Brennen Medical, LLC | KGN |
| Oct 14, 2011 | K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX Brennen Medical, LLC | FTM |
| Jul 31, 2008 | K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX Brennen Medical, LLC | FTM |
| Feb 17, 2006 | K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING Brennen Medical, Inc. | FRO |
| Mar 7, 2003 | K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. | PAG |
| Oct 17, 2002 | K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX Brennen Medical, Inc. | FTL |
| Oct 2, 2000 | K002078 | BETA GLUCAN GEL (MACROPRO GEL) Brennen Medical, Inc. | MGQ |
| Oct 2, 2000 | K002077 | GLUCANPRO CREAM Brennen Medical, Inc. | MGQ |
| May 1, 2000 | K000519 | GLUCANPRO Brennen Medical, Inc. | MGQ |
| May 1, 2000 | K000518 | MACROPRO GEL Brennen Medical, Inc. | MGQ |
| Nov 6, 1998 | K982825 | BRENNEN MEDICAL BETA GLUCAN GEL Brennen Medical, Inc. | MGQ |
| Sep 22, 1998 | K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. | PAG |
| Jul 29, 1998 | K980962 | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO Brennen Medical, Inc. | MGQ |
| Dec 12, 1996 | K964241 | BRENNEN MEDICAL GLUCAN II WOUND DRESSING Brennen Medical, Inc. | MGQ |
| Dec 5, 1996 | K963128 | NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. | MDA |
| Jun 28, 1995 | K950032 | MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING Brennen Medical, Inc. | KGN |
| Apr 13, 1995 | K950281 | MESH MATRIX WOUND DRESSING Brennen Medical, Inc. | KGN |
| Jul 11, 1994 | K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING Brennen Medical, Inc. | KGN |
| May 31, 1994 | K941125 | NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. | MDA |
| Jan 10, 1994 | K935060 | BRENNEN MEDICAL STERILE SALINE SOLUTION Brennen Medical, Inc. | KMF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||