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
2569–2592 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 19, 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 76d
Cleared Dec 15, 1994
ADVANCE CORP. SUNGLASSES
K944235 · HQY
Advance Corp.
Ophthalmic · 106d
Cleared Dec 15, 1994
SUNGLASSES
K944398 · HQY
Sun Island Enterprise Co., Ltd.
Ophthalmic · 97d
Cleared Dec 15, 1994
GOGGLE SAFEGUARD
K944857 · HOY
Sellstrom Mfg. Co.
Ophthalmic · 76d
Cleared Dec 15, 1994
SPECTACLE FRAME OR EYEGLASS FRAMES
K945176 · HQZ
Optipia Trading Co.
Ophthalmic · 52d
Cleared Dec 15, 1994
SPECTACLE FRAME
K945392 · HQZ
Seo Han Corp., Ltd.
Ophthalmic · 42d
Cleared Dec 15, 1994
OPTICAL FRAMES
K945770 · HQZ
Ramada Optics, Inc.
Ophthalmic · 43d
Cleared Dec 13, 1994
FRAME, SPECTACLES
K945350 · HQZ
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 90d
Cleared Dec 13, 1994
SHIELD, EYE, OPHTHALMIC
K945351 · HOY
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 90d
Cleared Dec 07, 1994
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
K924277 · HLT
Chalgren Enterprises, Inc.
Ophthalmic · 834d
Cleared Dec 07, 1994
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2
K944207 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 100d
Cleared Dec 07, 1994
ACCUCON
K944223 · HQD
Innovision, Inc.
Ophthalmic · 99d
Cleared Dec 07, 1994
MULTIPLE
K945282 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 40d
Cleared Dec 07, 1994
MULTIPLE
K945341 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 36d
Cleared Dec 05, 1994
CASSETTE SYSTEM FOR STORZ
K942945 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 166d
Cleared Dec 05, 1994
COLLEGIATE COLORS
K945006 · HQY
Trey Optics
Ophthalmic · 53d
Cleared Nov 28, 1994
STORZ PHACO AND FRAG HANDPIECES
K935926 · HQC
Storz Instrument Co.
Ophthalmic · 350d
Cleared Nov 28, 1994
MAG-1 SPECTACLE FRAME
K945342 · HQZ
Criss Optical Mfg. Co., Inc.
Ophthalmic · 27d
Cleared Nov 22, 1994
UNBREAKABLE LENS
K941437 · HQY
Nam Hing Plastic Factory , Ltd.
Ophthalmic · 243d
Cleared Nov 22, 1994
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · HNO
Chiron Vision Corp.
Ophthalmic · 237d
Cleared Nov 22, 1994
KEELER MULTILASE 3000
K942180 · HQF
Keeler Instruments, Inc.
Ophthalmic · 202d
Cleared Nov 22, 1994
SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR
K944312 · HQY
Shelin International Ent., Inc.
Ophthalmic · 81d
Cleared Nov 22, 1994
FOCOMETER
K944402 · HLJ
Lacrimedics, Inc.
Ophthalmic · 71d
Cleared Nov 22, 1994
KERATRON CORNEAL TOPOGRAPHER
K944616 · HLQ
Alliance Medical Marketinig
Ophthalmic · 63d