Atlas FDA

HPZ

39 FDA 510(k) clearances · Product code

98 daysmedian time to decision
287 days90th percentile
39clearances measured

FDA profile

Official device name
Implant, Eye Sphere
Device class
Class II (moderate risk)
Regulation
21 CFR 886.3320
Medical specialty
Ophthalmic
Flags
Implant
Adverse events (MAUDE)
2003: 1 · 2007: 5 · 2008: 7 · 2009: 5 · 2010: 3 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EZYPOR (K212741)Fci (France Chirurgie Instrumentation) Sas2022-06-24
DURETTE OCULAR IMPLANT (K123764)Oculo-Plastik, Inc.2013-01-31
BIOCERAMIC ORBITAL IMPLANT, ORBTEX (K110554)Ceramisys, Ltd.2011-11-02
SILICONE SPHERES (K112176)Oculo Plastik, Inc.2011-09-15
ORBITAL RECONSTRUCTIVE IMPLANT II (K083342)Evera Medical, Inc.2009-03-12
EYE SPHERES (K082850)Product and Educational Services, LLC2009-02-27
DURETTE IMPLANT (K073293)Oculo Plastik, Inc.2008-03-19
MEDPOR ATTRACTOR IMPLANT (K071335)Porex Surgical, Inc.2007-08-08
ORBITAL RECONSTRUCTIVE IMPLANT (K070130)Becker & Associates Consulting, Inc.2007-04-19
ALPHASPHERE ORBITAL IMPLANT (K053298)Hydron Pty Limited2006-05-09
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (K040851)Porex Surgical, Inc.2004-07-16
EYE SPHERE IMPLANTS (K040689)Oculo Plastik, Inc.2004-06-10
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (K023400)Fci Ophthalmics, Inc.2003-08-22
HA ORBITAL IMPLANT (K021643)Laboratoire Villanova2002-12-13
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (K021357)Porex Surgical, Inc.2002-08-05
MEDPOR QUAD MOTILITY IMPLANT (K010902)Porex Surgical, Inc.2001-06-19
BIO-EYE II ORBITAL IMPLANT (K003338)Integrated Orbital Implants, Inc.2001-02-07
BIOCERAMIC ORBITAL IMPLANT (K992294)Fci Ophthalmics, Inc.2000-04-19
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (K982562)Integrated Orbital Implants, Inc.1998-12-28
MOA BONE / M-SPHERE (K972143)Iop, Inc.1997-10-16
EYE SPHERE, CONFORMERS (K972661)Gulden Ophthalmics1997-10-03
GORE SPHEREX IMPLANT (K962241)W. L. Gore & Associates, Inc.1996-08-22
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES (K960859)Porex Technologies Corp. of Georgia1996-05-29
MEDPOR OCULAR SCREW & ACCESSORIES (K954939)Porex Surgical, Inc.1996-01-25
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT (K941717)Miguel Martinez M.D.1995-02-14
MEDPOR SURGICAL IMPLANT MATERIAL (K943275)Porex Surgical, Inc.1994-09-02
EPTFE SHEET COVERING FOR OCULAR IMPLANT (K934834)Oculo Plastik, Inc.1994-05-05
MARTINEZ ORBITAL IMPLANT (K935251)Miguel Martinez M.D.1994-03-01
STERILE/SINGLE USE EYE SPHERE IMPLANTS (K921106)Storz Instrument Co.1992-03-30
OPHTIMPLANT (K915630)Oculo Plastik, Inc.1992-03-02
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS (K911110)G.W.B. Intl., Ltd.1991-06-18
NEW IOWA MOTILITY IMPLANT (K900080)Oculo Plastik, Inc.1990-03-23
NEW ALLEN IMPLANT (K900081)Oculo Plastik, Inc.1990-03-23
MULES SPHERE GLASS (SEVERAL SIZES) (K895908)Ginsberg Scientific, Inc.1990-01-08
MOTILITY ORBITAL IMPLANT (K891137)Integrated Orbital Implants, Inc.1989-08-24
LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT (K873578)Oculo-Plastik Reg'D1987-11-02
POREX(TM) EYE SPHERE IMPLANT (K863943)Porex Medical1987-02-27
MEDITRADE ARTIFICIAL EYES AND IMPLANTS (K862977)Meditrade, Inc.1986-10-20
IMPLANT, EYE SPHERE (K781356)Mcghan Medical Corp.1978-08-21

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Every clearance here is in the API, with alerts when new ones post.