FDA Product Code
FDA Product Code HPZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3320
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 | Traditional | PDF ↗ |
| K123764 | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | 2013-01-31 | Traditional | PDF ↗ |
| K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | 2011-11-02 | Traditional | PDF ↗ |
| K112176 | SILICONE SPHERES | Oculo Plastik, Inc. | 2011-09-15 | Special | PDF ↗ |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | 2009-03-12 | Traditional | PDF ↗ |
| K082850 | EYE SPHERES | Product and Educational Services, LLC | 2009-02-27 | Traditional | PDF ↗ |
| K073293 | DURETTE IMPLANT | Oculo Plastik, Inc. | 2008-03-19 | Traditional | PDF ↗ |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | 2007-08-08 | Traditional | PDF ↗ |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | 2007-04-19 | Traditional | PDF ↗ |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | 2006-05-09 | Traditional | PDF ↗ |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | 2004-07-16 | Traditional | PDF ↗ |
| K040689 | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | 2004-06-10 | Traditional | PDF ↗ |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | 2003-08-22 | Traditional | PDF ↗ |
| K021643 | HA ORBITAL IMPLANT | Laboratoire Villanova | 2002-12-13 | Traditional | PDF ↗ |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | 2002-08-05 | Traditional | PDF ↗ |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | 2001-06-19 | Traditional | PDF ↗ |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | 2001-02-07 | Traditional | PDF ↗ |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | 2000-04-19 | Traditional | PDF ↗ |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | 1998-12-28 | Traditional | PDF ↗ |
| K972143 | MOA BONE / M-SPHERE | Iop, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K972661 | EYE SPHERE, CONFORMERS | Gulden Ophthalmics | 1997-10-03 | Traditional | PDF ↗ |
| K962241 | GORE SPHEREX IMPLANT | W. L. Gore & Associates, Inc. | 1996-08-22 | Traditional | PDF ↗ |
| K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES | Porex Technologies Corp. of Georgia | 1996-05-29 | Traditional | PDF ↗ |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | Porex Surgical, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K941717 | MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT | Miguel Martinez M.D. | 1995-02-14 | Traditional | PDF ↗ |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | Porex Surgical, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | Oculo Plastik, Inc. | 1994-05-05 | Traditional | PDF ↗ |
| K935251 | MARTINEZ ORBITAL IMPLANT | Miguel Martinez M.D. | 1994-03-01 | Traditional | PDF ↗ |
| K921106 | STERILE/SINGLE USE EYE SPHERE IMPLANTS | Storz Instrument Co. | 1992-03-30 | Traditional | PDF ↗ |
| K915630 | OPHTIMPLANT | Oculo Plastik, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS | G.W.B. Intl., Ltd. | 1991-06-18 | Traditional | PDF ↗ |
| K900080 | NEW IOWA MOTILITY IMPLANT | Oculo Plastik, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K900081 | NEW ALLEN IMPLANT | Oculo Plastik, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K895908 | MULES SPHERE GLASS (SEVERAL SIZES) | Ginsberg Scientific, Inc. | 1990-01-08 | Traditional | PDF ↗ |
| K891137 | MOTILITY ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | 1989-08-24 | Traditional | PDF ↗ |
| K873578 | LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT | Oculo-Plastik Reg'D | 1987-11-02 | Traditional | PDF ↗ |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Porex Medical | 1987-02-27 | Traditional | PDF ↗ |
| K862977 | MEDITRADE ARTIFICIAL EYES AND IMPLANTS | Meditrade, Inc. | 1986-10-20 | Traditional | PDF ↗ |
| K781356 | IMPLANT, EYE SPHERE | Mcghan Medical Corp. | 1978-08-21 | Traditional | PDF ↗ |
Product code HPZ · Class II · Ophthalmic. Data: openFDA.