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
2233–2256 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 25, 1996
SOMA
K962725 · HQY
Soma International , Ltd.
Ophthalmic · 10d
Cleared Jul 25, 1996
SUNGLASSES (NON-PRESCRIPTION)
K962775 · HQY
Canadd Trading Co.
Ophthalmic · 9d
Cleared Jul 23, 1996
MEGATRON OPHTHALMIC SURGICAL SYSTEM
K961658 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 85d
Cleared Jul 23, 1996
CTM REUSABLE PAK
K962430 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 23, 1996
CTM DISPOSABLE PAK
K962431 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 19, 1996
DIOPEXY PROBE
K960522 · HQF
Iriderm Div.
Ophthalmic · 164d
Cleared Jul 18, 1996
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · HKY
Clement Clarke, Inc.
Ophthalmic · 90d
Cleared Jul 15, 1996
MBI FIBEROPTIC ENDO-ILLUMINATOR
K961036 · MPA
M.B. Industries, Inc.
Ophthalmic · 123d
Cleared Jul 12, 1996
BOSTON CONTACT LENS CASE
K962512 · LRX
Polymer Technology Div. Wilmington...
Ophthalmic · 15d
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