Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Implant, Eye Sphere

FDA product code HPZ · 39 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.3320
Review panel: OP
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-08-21 – 2022-06-24

HPZ 2022-06-24

EZYPOR

Applicant Fci (France Chirurgie Instrumentation) Sas

K number K212741

View details →

HPZ 2013-01-31

DURETTE OCULAR IMPLANT

Applicant Oculo-Plastik, Inc.

K number K123764

View details →

HPZ 2011-11-02

BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Applicant Ceramisys, Ltd.

K number K110554

View details →

HPZ 2011-09-15

SILICONE SPHERES

Applicant Oculo Plastik, Inc.

K number K112176

View details →

HPZ 2009-03-12

ORBITAL RECONSTRUCTIVE IMPLANT II

Applicant Evera Medical, Inc.

K number K083342

View details →

HPZ 2009-02-27

EYE SPHERES

Applicant Product and Educational Services, LLC

K number K082850

View details →

HPZ 2008-03-19

DURETTE IMPLANT

Applicant Oculo Plastik, Inc.

K number K073293

View details →

HPZ 2007-08-08

MEDPOR ATTRACTOR IMPLANT

Applicant Porex Surgical, Inc.

K number K071335

View details →

HPZ 2007-04-19

ORBITAL RECONSTRUCTIVE IMPLANT

Applicant Becker & Associates Consulting, Inc.

K number K070130

View details →

HPZ 2006-05-09

ALPHASPHERE ORBITAL IMPLANT

Applicant Hydron Pty Limited

K number K053298

View details →

HPZ 2004-07-16

MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM

Applicant Porex Surgical, Inc.

K number K040851

View details →

HPZ 2004-06-10

EYE SPHERE IMPLANTS

Applicant Oculo Plastik, Inc.

K number K040689

View details →

HPZ 2003-08-22

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

Applicant Fci Ophthalmics, Inc.

K number K023400

View details →

HPZ 2002-12-13

HA ORBITAL IMPLANT

Applicant Laboratoire Villanova

K number K021643

View details →

HPZ 2002-08-05

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

Applicant Porex Surgical, Inc.

K number K021357

View details →

HPZ 2001-06-19

MEDPOR QUAD MOTILITY IMPLANT

Applicant Porex Surgical, Inc.

K number K010902

View details →

HPZ 2001-02-07

BIO-EYE II ORBITAL IMPLANT

Applicant Integrated Orbital Implants, Inc.

K number K003338

View details →

HPZ 2000-04-19

BIOCERAMIC ORBITAL IMPLANT

Applicant Fci Ophthalmics, Inc.

K number K992294

View details →

HPZ 1998-12-28

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

Applicant Integrated Orbital Implants, Inc.

K number K982562

View details →

HPZ 1997-10-16

MOA BONE / M-SPHERE

Applicant Iop, Inc.

K number K972143

View details →

HPZ 1997-10-03

EYE SPHERE, CONFORMERS

Applicant Gulden Ophthalmics

K number K972661

View details →

HPZ 1996-08-22

GORE SPHEREX IMPLANT

Applicant W. L. Gore & Associates, Inc.

K number K962241

View details →

HPZ 1996-05-29

MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES

Applicant Porex Technologies Corp. of Georgia

K number K960859

View details →

HPZ 1996-01-25

MEDPOR OCULAR SCREW & ACCESSORIES

Applicant Porex Surgical, Inc.

K number K954939

View details →

HPZ 1995-02-14

MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT

Applicant Miguel Martinez M.D.

K number K941717

View details →

HPZ 1994-09-02

MEDPOR SURGICAL IMPLANT MATERIAL

Applicant Porex Surgical, Inc.

K number K943275

View details →

HPZ 1994-05-05

EPTFE SHEET COVERING FOR OCULAR IMPLANT

Applicant Oculo Plastik, Inc.

K number K934834

View details →

HPZ 1994-03-01

MARTINEZ ORBITAL IMPLANT

Applicant Miguel Martinez M.D.

K number K935251

View details →

HPZ 1992-03-30

STERILE/SINGLE USE EYE SPHERE IMPLANTS

Applicant Storz Instrument Co.

K number K921106

View details →

HPZ 1992-03-02

OPHTIMPLANT

Applicant Oculo Plastik, Inc.

K number K915630

View details →

HPZ 1991-06-18

OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS

Applicant G.W.B. Intl., Ltd.

K number K911110

View details →

HPZ 1990-03-23

NEW ALLEN IMPLANT

Applicant Oculo Plastik, Inc.

K number K900081

View details →

HPZ 1990-03-23

NEW IOWA MOTILITY IMPLANT

Applicant Oculo Plastik, Inc.

K number K900080

View details →

HPZ 1990-01-08

MULES SPHERE GLASS (SEVERAL SIZES)

Applicant Ginsberg Scientific, Inc.

K number K895908

View details →

HPZ 1989-08-24

MOTILITY ORBITAL IMPLANT

Applicant Integrated Orbital Implants, Inc.

K number K891137

View details →

HPZ 1987-11-02

LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT

Applicant Oculo-Plastik Reg'D

K number K873578

View details →

HPZ 1987-02-27

POREX(TM) EYE SPHERE IMPLANT

Applicant Porex Medical

K number K863943

View details →

HPZ 1986-10-20

MEDITRADE ARTIFICIAL EYES AND IMPLANTS

Applicant Meditrade, Inc.

K number K862977

View details →

HPZ 1978-08-21

IMPLANT, EYE SPHERE

Applicant Mcghan Medical Corp.

K number K781356

View details →

↑