FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
3385–3408 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 26, 1991
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
K911998 · HQE
Allergan Medical Optics
Ophthalmic · 88d
Cleared Jul 25, 1991
TBD, LENS MEASURING DEVICE
K912134 · HRJ
Alcon Laboratories
Ophthalmic · 72d
Cleared Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
K912151 · HNH
Ocular Instruments, Inc.
Ophthalmic · 71d
Cleared Jul 05, 1991
EASY EYES TM CONTACT LENS CLEANING MACHINE
K904824 · LYL
Eaton Medical Corp.
Ophthalmic · 253d
Cleared Jun 25, 1991
SLIMCATH (TM)
K903001 · HIT
Gynopharma, Inc.
Ophthalmic · 351d
Cleared Jun 25, 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721 · HKX
Keeler Instruments, Inc.
Ophthalmic · 69d
Cleared Jun 25, 1991
GEMINI OPHTHALMIC SURGERY SYSTEM
K911808 · HQC
Alcon Laboratories
Ophthalmic · 63d
Cleared Jun 25, 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
K912366 · HJK
Ocular Instruments, Inc.
Ophthalmic · 27d
Cleared Jun 18, 1991
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
K911110 · HPZ
G.W.B. Intl., Ltd.
Ophthalmic · 106d
Cleared Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · HKI
Canon USA, Inc.
Ophthalmic · 76d
Cleared Jun 17, 1991
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
K912112 · LQJ
Tomey Corporation USA
Ophthalmic · 35d
Cleared Jun 10, 1991
COLLAGEN SHIELD, VARIOUS MODELS
K905825 · MOE
Chiron Ophthalmics
Ophthalmic · 161d
Cleared Jun 06, 1991
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K905427 · LZU
Eagle Vision, Inc.
Ophthalmic · 184d
Cleared Jun 06, 1991
ORIGINALS
K911277 · HQY
Face 2 Face Corp.
Ophthalmic · 73d
Cleared May 28, 1991
URAM OPHTHALMIC LASER ENDOSCOPE
K910532 · HQF
Martin S. Knopf Assoc., Inc.
Ophthalmic · 109d
Cleared May 24, 1991
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · HQF
Heraeus Lasersonics, Inc.
Ophthalmic · 87d
Cleared May 22, 1991
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K910980 · HJO
Site Microsurgical Systems, Inc.
Ophthalmic · 76d
Cleared May 22, 1991
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · HNO
Storz Instrument Co.
Ophthalmic · 72d
Cleared May 22, 1991
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.
K911766 · HQY
Gall'S, Inc.
Ophthalmic · 33d
Cleared May 14, 1991
PATHFINDER
K910601 · HPG
Nurion Industries
Ophthalmic · 90d
Cleared May 13, 1991
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K911108 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 70d
Cleared May 06, 1991
OPTHLAMIC FRAMES
K910951 · HQZ
United Optical, Spa
Ophthalmic · 62d
Cleared May 06, 1991
SPECTACLE FRAME
K911332 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 41d
Cleared May 01, 1991
SUNGLASSES
K910415 · HQY
K.M Optical Co.
Ophthalmic · 91d