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
1705–1728 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K000164 · LPN
Allergan, Inc.
Ophthalmic · 135d
Cleared May 26, 2000
RIGID GAS PERMEABLE CONTACT LENS
K000795 · HQD
Polymer Technology
Ophthalmic · 74d
Cleared May 26, 2000
OPTIMUM WETTING AND REWETTING DROP
K001428 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d
Cleared May 22, 2000
SPORTSIGHT GP
K993586 · HQD
Paragon Vision Sciences
Ophthalmic · 213d
Cleared May 19, 2000
MENICON Z
K000133 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 122d
Cleared May 19, 2000
MENICON SF-P
K000233 · HQD
Menicon Co, Ltd.
Ophthalmic · 113d
Cleared May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
K000637 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 84d
Cleared May 19, 2000
POLYMACON
K001089 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared May 19, 2000
METHAFILCON A
K001090 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared May 15, 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · MRC
Ciba Vision Corporation
Ophthalmic · 82d
Cleared May 12, 2000
HYDRO2, HS-75
K000485 · HQD
Innovision, Inc.
Ophthalmic · 88d
Cleared May 11, 2000
HEADLAMP HL2000.
K994362 · FSR
Angiolaz, Inc.
Ophthalmic · 136d
Cleared May 09, 2000
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES
K000457 · HMX
Retinalabs.Com
Ophthalmic · 88d
Cleared May 08, 2000
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
K000416 · MPA
Retinalabs.Com
Ophthalmic · 90d
Cleared May 08, 2000
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
K000420 · MRH
Retinalabs.Com
Ophthalmic · 90d
Cleared May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 25d
Cleared May 04, 2000
EYECAP IMAGING SYSTEM
K000368 · HKI
Clement Clarke Intl., Ltd.
Ophthalmic · 90d
Cleared May 02, 2000
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K000327 · HKO
Visx, Incorporated
Ophthalmic · 90d
Cleared Apr 28, 2000
OPTI-FREE EXPRESS LENS DROPS
K000385 · MRC
Alcon Universal, Ltd.
Ophthalmic · 81d
Cleared Apr 21, 2000
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 14d
Cleared Apr 20, 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Apr 19, 2000
BIOCERAMIC ORBITAL IMPLANT
K992294 · HPZ
Fci Ophthalmics, Inc.
Ophthalmic · 287d
Cleared Apr 17, 2000
FLUROPERM 60-OK, PARAGON HDS-OK
K000224 · MUW
Paragon Vision Sciences
Ophthalmic · 84d
Cleared Apr 17, 2000
SUTUREGROOVE
K994289 · MML
Iop, Inc.
Ophthalmic · 118d