Company ยท US
Porex Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2011. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HPZ | Implant, Eye Sphere | 7 |
| FWP | Prosthesis, Chin, Internal | 2 |
| HQN | Conformer, Ophthalmic | 2 |
| LYA | Splint, Intranasal Septal | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 |
| FTM | Mesh, Surgical | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 |
| HBW | Fastener, Plate, Cranioplasty | 1 |
| JEY | Plate, Bone | 1 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 1 |
| OKS | Lacrimal Stents And Intubation Sets | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2011 | K102184 | MEDPOR CONTAIN CAN IMPLANT Porex Surgical, Inc. | NPK |
| Dec 3, 2010 | K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 Porex Surgical, Inc. | HBW |
| Jun 28, 2010 | K091807 | MEDPOR FIXATION SYSTEM Porex Surgical, Inc. | JEY |
| Mar 19, 2010 | K091120 | MEDPOR CONTAIN IMPLANT Porex Surgical, Inc. | NPK |
| Feb 3, 2009 | K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT Porex Surgical, Inc. | JOF |
| Aug 8, 2007 | K071335 | MEDPOR ATTRACTOR IMPLANT Porex Surgical, Inc. | HPZ |
| Mar 28, 2006 | K052297 | POREX ELECTROSURGERY NEEDLE Porex Surgical, Inc. | GEI |
| Jul 16, 2004 | K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM Porex Surgical, Inc. | HPZ |
| Jun 30, 2004 | K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH Porex Surgical, Inc. | FTM |
| Aug 5, 2002 | K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT Porex Surgical, Inc. | HPZ |
| Mar 14, 2002 | K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL Porex Surgical, Inc. | FWP |
| Dec 19, 2001 | K012108 | MEDPOR COATED TEAR DRAIN Porex Surgical, Inc. | OKS |
| Jun 19, 2001 | K010902 | MEDPOR QUAD MOTILITY IMPLANT Porex Surgical, Inc. | HPZ |
| Sep 8, 1998 | K982040 | MEDPOR SURGICAL GRANULE IMPLANTS Porex Surgical, Inc. | GXP |
| Jul 2, 1998 | K981374 | POREX NOSTRIL RETAINERS Porex Surgical, Inc. | LYA |
| Jan 20, 1998 | K972034 | MEDPOR OCULAR CONFORMER Porex Surgical, Inc. | HQN |
| Jan 25, 1996 | K954939 | MEDPOR OCULAR SCREW & ACCESSORIES Porex Surgical, Inc. | HPZ |
| Aug 21, 1995 | K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL Porex Surgical, Inc. | FWP |
| Sep 2, 1994 | K943275 | MEDPOR SURGICAL IMPLANT MATERIAL Porex Surgical, Inc. | HPZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Porex Surgical, Inc. Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265.
The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process Terminated |
HQN | K972034 |
| Sep 22, 2006 | Porex Surgical, Inc. Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA. Terminated |
LYA | None listed |
| Apr 16, 2005 | Porex Surgical, Inc. MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Roa Terminated |
HPZ | K863943 |