Panels › Ophthalmic › Product code HPZ · Class 2
Implant, Eye Sphere
Regulation 886.3320
0510(k)s in 12 months (39 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in HPZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Oculo Plastik, Inc. | 8 | 0 |
| Porex Surgical, Inc. | 6 | 1 |
| Integrated Orbital Implants, Inc. | 3 | 3 |
| Fci Ophthalmics, Inc. | 2 | 0 |
| Miguel Martinez M.D. | 2 | 0 |
| Becker & Associates Consulting, Inc. | 1 | 0 |
| Ceramisys, Ltd. | 1 | 0 |
| Evera Medical, Inc. | 1 | 0 |
| Fci (France Chirurgie Instrumentation) Sas | 1 | 0 |
| G.W.B. Intl., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2012 | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye gl Terminated |
HPZ | K021357 |
| Jun 22, 2011 | Integrated Orbital Implants Inc Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer.
Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital.
Model Number: I0016C, I0018C, I0020C, I0022C, I0024C.
Description o Terminated |
HPZ | K003338 |
| Aug 26, 2010 | Integrated Orbital Implants Inc Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer Terminated |
HPZ | K982562 |
| Oct 4, 2006 | Integrated Orbital Implants Inc Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S Terminated |
HPZ | K982562 |
| 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 |
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