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
1897–1920 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 09, 1998
MONARCH IOL DELIVERY SYSTEM
K981571 · KYB
Alcon Laboratories
Ophthalmic · 66d
Cleared Jul 06, 1998
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
K974837 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 194d
Cleared Jul 06, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K980775 · LPN
Allergan, Inc.
Ophthalmic · 126d
Cleared Jul 06, 1998
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
K981574 · LPN
Alcon
Ophthalmic · 63d
Cleared Jun 24, 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 127d
Cleared Jun 24, 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K981779 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 35d
Cleared Jun 23, 1998
AUTOMATED CORNEAL TREPHINE
K981063 · HRG
Laser Center Dev. Corp.
Ophthalmic · 92d
Cleared Jun 23, 1998
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K981103 · HQC
Alcon Laboratories
Ophthalmic · 89d
Cleared Jun 23, 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS...
K981252 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared Jun 22, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING,...
K981151 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jun 17, 1998
MEDITEC LINK
K981196 · HQF
Aesculap-Meditec North America
Ophthalmic · 90d
Cleared Jun 09, 1998
QUITETIP
K981109 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 74d
Cleared Jun 01, 1998
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
K980100 · MSR
Storz Instrument Co.
Ophthalmic · 140d
Cleared May 19, 1998
CATARACT LIQUEFRACTURE DEVICE
K980292 · MUS
Alcon Laboratories
Ophthalmic · 113d
Cleared May 19, 1998
OPHTHAVISION IMAGING SYSTEM
K980295 · HKI
Mrp Group, Inc.
Ophthalmic · 112d
Cleared May 19, 1998
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
K980797 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 78d
Cleared May 19, 1998
SOVEREIGN CATARACT EXTRACTION SYSTEM
K981116 · KYG
Allergan, Inc.
Ophthalmic · 53d
Cleared May 15, 1998
EYE IRRIGATOR MODEL #2020
K980647 · KYG
Eye-Deal Ocular Safety Products, Inc.
Ophthalmic · 87d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT,...
K980649 · LPL
CooperVision, Inc.
Ophthalmic · 83d
Cleared May 12, 1998
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12...
K980530 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 90d
Cleared May 11, 1998
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
K980741 · HQD
Polymer Technology Div. Wilmington...
Ophthalmic · 74d
Cleared May 11, 1998
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · LZU
Advanced Vision Science
Ophthalmic · 68d
Cleared May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · HKI
Canon USA, Inc.
Ophthalmic · 103d
Cleared May 04, 1998
SYNTEC VITMAN
K980480 · HQC
Syntec, Inc.
Ophthalmic · 90d