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
2377–2400 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 06, 1995
PHACO TIP
K950881 · HQC
American Optical Corp.
Ophthalmic · 191d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER
K952580 · MPA
Gamp & Assoc.
Ophthalmic · 88d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK
K952584 · MPA
Gamp & Assoc.
Ophthalmic · 88d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
K952586 · MPA
Gamp & Assoc.
Ophthalmic · 88d
Cleared Aug 25, 1995
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
K952480 · HKI
Midwest Ophthalmic Instruments, Inc.
Ophthalmic · 87d
Cleared Aug 24, 1995
HI-LINE MEDICAL PHACOEMULSIFIER TIP
K952468 · HQC
Hi-Line Medical
Ophthalmic · 90d
Cleared Aug 23, 1995
SPECTACLE SUNGLASSES(NON-PRESCRIPTION)
K953629 · HQY
Lowinger Holdings, Inc.
Ophthalmic · 30d
Cleared Aug 22, 1995
ZEIMER SELF TONOMETER
K953031 · HKX
Cds Technologies
Ophthalmic · 90d
Cleared Aug 17, 1995
DIGITAL AVERAGING TONOMETER
K945972 · HKX
Opti-Med Electronics
Ophthalmic · 252d
Cleared Aug 16, 1995
AOI LC-40 PHACOEMULSIFIER
K952331 · HQC
American Optisurgical, Inc.
Ophthalmic · 90d
Cleared Aug 14, 1995
SUNGLASSES
K941084 · HQY
Blue Gem Sunglasses, Inc.
Ophthalmic · 524d
Cleared Aug 14, 1995
MING-YA OPTICAL INDUSTRIALCO., LTD.
K951801 · HQY
Min-Ya Optical Industrial Co., Ltd.
Ophthalmic · 118d
Cleared Aug 14, 1995
VISULINK 900 ARGON
K952894 · HQF
Carl Zeiss, Inc.
Ophthalmic · 52d
Cleared Aug 09, 1995
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · HQC
Alcon Laboratories
Ophthalmic · 90d
Cleared Aug 08, 1995
HENNERT SA
K952734 · HQY
Hennert S.A.
Ophthalmic · 54d
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