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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2022 | K212741 | EZYPOR Fci (France Chirurgie Instrumentation) Sas, FR | HPZ |
| Jan 31, 2013 | K123764 | DURETTE OCULAR IMPLANT Oculo-Plastik, Inc., CA | HPZ |
| Nov 2, 2011 | K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX Ceramisys, Ltd. | HPZ |
| Sep 15, 2011 | K112176 | SILICONE SPHERES Oculo Plastik, Inc., CA | HPZ |
| Mar 12, 2009 | K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II Evera Medical, Inc. | HPZ |
| Feb 27, 2009 | K082850 | EYE SPHERES Product and Educational Services, LLC | HPZ |
| Mar 19, 2008 | K073293 | DURETTE IMPLANT Oculo Plastik, Inc., CA | HPZ |
| Aug 8, 2007 | K071335 | MEDPOR ATTRACTOR IMPLANT Porex Surgical, Inc. | HPZ |
| Apr 19, 2007 | K070130 | ORBITAL RECONSTRUCTIVE IMPLANT Becker & Associates Consulting, Inc. | HPZ |
| May 9, 2006 | K053298 | ALPHASPHERE ORBITAL IMPLANT Hydron Pty Limited | HPZ |
| Jul 16, 2004 | K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM Porex Surgical, Inc. | HPZ |
| Jun 10, 2004 | K040689 | EYE SPHERE IMPLANTS Oculo Plastik, Inc., CA | HPZ |
| Aug 22, 2003 | K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT Fci Ophthalmics, Inc. | HPZ |
| Dec 13, 2002 | K021643 | HA ORBITAL IMPLANT Laboratoire Villanova, FR | HPZ |
| Aug 5, 2002 | K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT Porex Surgical, Inc. | HPZ |
| Jun 19, 2001 | K010902 | MEDPOR QUAD MOTILITY IMPLANT Porex Surgical, Inc. | HPZ |
| Feb 7, 2001 | K003338 | BIO-EYE II ORBITAL IMPLANT Integrated Orbital Implants, Inc. | HPZ |
| Apr 19, 2000 | K992294 | BIOCERAMIC ORBITAL IMPLANT Fci Ophthalmics, Inc. | HPZ |
| Dec 28, 1998 | K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER Integrated Orbital Implants, Inc. | HPZ |
| Oct 16, 1997 | K972143 | MOA BONE / M-SPHERE Iop, Inc. | HPZ |
| Oct 3, 1997 | K972661 | EYE SPHERE, CONFORMERS Gulden Ophthalmics | HPZ |
| Aug 22, 1996 | K962241 | GORE SPHEREX IMPLANT W. L. Gore & Associates, Inc. | HPZ |
| May 29, 1996 | K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES Porex Technologies Corp. of Georgia | HPZ |
| Jan 25, 1996 | K954939 | MEDPOR OCULAR SCREW & ACCESSORIES Porex Surgical, Inc. | HPZ |
| Feb 14, 1995 | K941717 | MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT Miguel Martinez M.D. | HPZ |
| Sep 2, 1994 | K943275 | MEDPOR SURGICAL IMPLANT MATERIAL Porex Surgical, Inc. | HPZ |
| May 5, 1994 | K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT Oculo Plastik, Inc., CA | HPZ |
| Mar 1, 1994 | K935251 | MARTINEZ ORBITAL IMPLANT Miguel Martinez M.D. | HPZ |
| Mar 30, 1992 | K921106 | STERILE/SINGLE USE EYE SPHERE IMPLANTS Storz Instrument Co. | HPZ |
| Mar 2, 1992 | K915630 | OPHTIMPLANT Oculo Plastik, Inc., CA | HPZ |
| Jun 18, 1991 | K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS G.W.B. Intl., Ltd. | HPZ |
| Mar 23, 1990 | K900081 | NEW ALLEN IMPLANT Oculo Plastik, Inc., CA | HPZ |
| Mar 23, 1990 | K900080 | NEW IOWA MOTILITY IMPLANT Oculo Plastik, Inc., CA | HPZ |
| Jan 8, 1990 | K895908 | MULES SPHERE GLASS (SEVERAL SIZES) Ginsberg Scientific, Inc. | HPZ |
| Aug 24, 1989 | K891137 | MOTILITY ORBITAL IMPLANT Integrated Orbital Implants, Inc. | HPZ |
| Nov 2, 1987 | K873578 | LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT Oculo-Plastik Reg'D, CA | HPZ |
| Feb 27, 1987 | K863943 | POREX(TM) EYE SPHERE IMPLANT Porex Medical | HPZ |
| Oct 20, 1986 | K862977 | MEDITRADE ARTIFICIAL EYES AND IMPLANTS Meditrade, Inc. | HPZ |
| Aug 21, 1978 | K781356 | IMPLANT, EYE SPHERE Mcghan Medical Corp. | HPZ |
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