Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
2401–2424 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 07, 1995
GOUVERNEUR AUDIGIER
K952758 · HQY
Ets Gouverneur-Audigier
Ophthalmic · 52d
Cleared Aug 07, 1995
ROYAL FLASH
K952939 · HQY
Royal Flash Enterprise Co. , Ltd.
Ophthalmic · 42d
Cleared Aug 07, 1995
STORZ DP4101 BASIC I/A PACK
K953078 · HQC
Storz Instrument Co.
Ophthalmic · 35d
Cleared Aug 07, 1995
OPTX 20/20
K953413 · HQY
Neoptx, Inc.
Ophthalmic · 18d
Cleared Aug 07, 1995
SUNGLASSES (NON-PRESCRIPTION)
K953473 · HQY
Cbi Dist.
Ophthalmic · 14d
Cleared Jul 31, 1995
HURRICANE
K952258 · HQY
Hurricane Hardware, Inc.
Ophthalmic · 77d
Cleared Jul 27, 1995
PROCLEAR DAILY WEAR CONTACT LENS
K952152 · LPL
Biocompatibles , Ltd.
Ophthalmic · 80d
Cleared Jul 26, 1995
BIO-COR COLLAGEN CORNEAL SHIELD
K944872 · MOE
Bausch & Lomb Healthcare and Optics...
Ophthalmic · 296d
Cleared Jul 25, 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · LPL
CooperVision, Inc.
Ophthalmic · 146d
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