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
2401–2424 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 24, 1995
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER...
K950914 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 151d
Cleared Jul 19, 1995
BOBES LENS SET
K945443 · HPC
Bobes S.A.
Ophthalmic · 254d
Cleared Jul 19, 1995
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
K951824 · HQC
Nidek, Inc.
Ophthalmic · 90d
Cleared Jul 19, 1995
FOSTER GRANT NON PRESCRIPTION SUNGLASSES
K953092 · HQY
Foster Grant Group
Ophthalmic · 16d
Cleared Jul 19, 1995
NYX GOLF VISION SYSTEM
K953245 · HQY
Nyx Golf, Inc.
Ophthalmic · 12d
Cleared Jul 19, 1995
SUNGLASSES
K953260 · HQY
Eye Deals
Ophthalmic · 7d
Cleared Jul 17, 1995
OMS SLIMLINE PHACO HANDPIECE
K950218 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 179d
Cleared Jul 17, 1995
FREDEIC BEAUSOCEIL
K951551 · HQY
Pascal Mathieux
Ophthalmic · 104d
Cleared Jul 17, 1995
SUNGLASSES
K951979 · HQY
Heyro Optical Manufactory
Ophthalmic · 81d
Cleared Jul 14, 1995
WELCH ALLYN FIBER OPTIC HEADLIGNT
K952289 · HPQ
Welch Allyn, Inc.
Ophthalmic · 59d
Cleared Jul 13, 1995
OXBORO-MEDICAL CAUTERY TIP CLEANER
K952784 · HQP
Oxboro Medical Intl., Inc.
Ophthalmic · 24d
Cleared Jul 12, 1995
SUNGLASSES
K952890 · HQY
Isohyper
Ophthalmic · 19d
Cleared Jul 12, 1995
METAL FRAM WITH POLYCARBONATE LENS
K953002 · HQY
Nakanishi Optical Products Corp.
Ophthalmic · 14d
Cleared Jul 12, 1995
SLIT LAMP AIA 11
K953030 · HJO
Naveen Intl., Inc.
Ophthalmic · 13d
Cleared Jul 11, 1995
DIPLOMAX
K946054 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 211d
Cleared Jul 05, 1995
HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM...
K952261 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 51d
Cleared Jun 30, 1995
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
K952165 · HQD
Rand Scientific Corp.
Ophthalmic · 88d
Cleared Jun 26, 1995
OPTI PADS
K950940 · LYL
Karlen Mfg., Inc.
Ophthalmic · 119d
Cleared Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 105d
Cleared Jun 26, 1995
BOSTON CONTACT LENS CASE
K951552 · LRX
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Jun 26, 1995
SUNGLASSES
K951815 · HQY
Fung Won Optical Mfg. Co.
Ophthalmic · 91d
Cleared Jun 26, 1995
ROBERT B. SCOTT PLASTIC ARTIFICAL
K952538 · HQH
Robert B. Scott Ocularists of...
Ophthalmic · 26d
Cleared Jun 20, 1995
BOBES TONOMETER
K945446 · HKY
Bobes S.A.
Ophthalmic · 225d
Cleared Jun 15, 1995
NEITZ SLIT LAMP SL-H2
K951341 · HJO
Neitz Instruments Company, Ltd.
Ophthalmic · 83d