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
2233–2256 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 10, 1996
OCUSYSTEM ART ADVANTAGE
K961243 · HQC
Surgical Design Corp.
Ophthalmic · 100d
Cleared Jul 03, 1996
NON-GENERIC
K962310 · HQY
Classic Elegance Intl., Inc.
Ophthalmic · 16d
Cleared Jul 03, 1996
NIKE V8 AND NIKE V12
K962412 · HQY
Nike, Inc.
Ophthalmic · 12d
Cleared Jul 02, 1996
SUNGLASSES
K962436 · HQY
Chungsin Kau Optical Mfy. Co. , Ltd.
Ophthalmic · 8d
Cleared Jun 27, 1996
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
K961310 · HQC
Storz Instrument Co.
Ophthalmic · 84d
Cleared Jun 24, 1996
MAGNETO EYEWEAR
K962169 · HQY
Nike, Inc.
Ophthalmic · 19d
Cleared Jun 20, 1996
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
K962107 · HQY
Leonachi, Inc.
Ophthalmic · 20d
Cleared Jun 17, 1996
AUTOMATIC VISUAL FIELD PLOTTER AP-125
K961090 · HPT
Kowa Optimed, Inc.
Ophthalmic · 90d
Cleared Jun 17, 1996
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242 · KYB
Allergan, Inc.
Ophthalmic · 77d
Cleared Jun 14, 1996
AUTOMATED VITRECTOMY DEVICE
K961078 · HQE
Promex, Inc.
Ophthalmic · 88d
Cleared Jun 06, 1996
NON-PRESCRIPTION SUNGLASSES
K961990 · HQY
Rokko Stars Co., Ltd.
Ophthalmic · 16d
Cleared Jun 05, 1996
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · HQX
Mira, Inc.
Ophthalmic · 469d
Cleared Jun 04, 1996
KOWA HAND-HELD APPLANATION TONOMETER HA-1
K960924 · HKY
Kowa Optimed, Inc.
Ophthalmic · 90d
Cleared May 31, 1996
MISTRAL SUNGLASSES
K960668 · HQY
Mistral Optical
Ophthalmic · 101d
Cleared May 31, 1996
SUNGLASSES
K960818 · HQY
Visard Srl
Ophthalmic · 93d
Cleared May 31, 1996
SUNGLASSES
K960953 · HQY
Galilee Optics
Ophthalmic · 81d
Cleared May 31, 1996
SUNGLASSES
K961146 · HQY
Erica Optical Co.
Ophthalmic · 71d
Cleared May 29, 1996
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · HPZ
Porex Technologies Corp. of Georgia
Ophthalmic · 89d
Cleared May 21, 1996
SOFT-55 DAILY WEAR CONTACT LENS
K961428 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 36d
Cleared May 20, 1996
THE CHEN MEDIUM
K954548 · LYX
Chen Ophthalmic Laboratories
Ophthalmic · 231d
Cleared May 16, 1996
SPECTACLE FRAMES/SUNGLASSES
K954419 · HQY
Ami Fashion
Ophthalmic · 238d
Cleared May 16, 1996
PMMA CLASIC
K955777 · HPX
Rand Scientific Corp.
Ophthalmic · 148d
Cleared May 16, 1996
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES
K961286 · HQY
Intl. Optical Mfg. Co., Ltd.
Ophthalmic · 43d
Cleared May 16, 1996
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS...
K961524 · HNY
Sterilab, Inc.
Ophthalmic · 24d