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
3601–3624 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 12, 1990
OPTISOL
K894162 · LYX
Chiron Ophthalmics
Ophthalmic · 212d
Cleared Jan 11, 1990
SOFT CORNEAL LIGHT SHIELD
K896681 · HOY
Visitec Co.
Ophthalmic · 45d
Cleared Jan 11, 1990
VISITEC MICRO-SPONGE SPEARS
K896705 · HOZ
Visitec Co.
Ophthalmic · 44d
Cleared Jan 11, 1990
I/A HANDPIECE
K896754 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 42d
Cleared Jan 08, 1990
MULES SPHERE GLASS (SEVERAL SIZES)
K895908 · HPZ
Ginsberg Scientific, Inc.
Ophthalmic · 90d
Cleared Dec 29, 1989
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
K895864 · LXS
Lasag AG
Ophthalmic · 87d
Cleared Dec 26, 1989
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · LRX
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Dec 26, 1989
PLASTIC SUNGLASSES
K896716 · HQY
Bright Horizon Ent.
Ophthalmic · 27d
Cleared Dec 26, 1989
NON-PRESCRIPTION SUNGLASSES
K896768 · HQY
Shairon Intl. Trade Co.
Ophthalmic · 25d
Cleared Dec 18, 1989
TWO MIRROR GONIO LENS
K895846 · HKS
Ocular Instruments, Inc.
Ophthalmic · 76d
Cleared Dec 18, 1989
MAINSTER WIDE FIELD LASER LENS
K896198 · HJK
Ocular Instruments, Inc.
Ophthalmic · 52d
Cleared Dec 18, 1989
MULTI-USE I/A HANDPIECE
K896305 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Dec 18, 1989
TITAN AIR SPECTACLE FRAME
K896350 · HQJ
Acces Intl. Eyewear
Ophthalmic · 42d
Cleared Dec 04, 1989
ALCON FOLDING FORCEPS
K895434 · HNR
Alcon Laboratories
Ophthalmic · 87d
Cleared Nov 27, 1989
D.L. SCOPE OPHTHALMOSCOPE
K896072 · HLJ
North American Medical Products, Inc.
Ophthalmic · 39d
Cleared Nov 14, 1989
POWERED EYE WASH
K893829 · MSI
Sacks Model Makers
Ophthalmic · 174d
Cleared Nov 03, 1989
EYE PATCH
K896171 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 03, 1989
STRAPPED EYE SHIELD
K896172 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 02, 1989
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · LZU
Lacrimedics, Inc.
Ophthalmic · 63d
Cleared Nov 02, 1989
PUPIL PATHWAY ANALYZER (PPA)
K895609 · HLG
Pulse Medical Instruments
Ophthalmic · 45d
Cleared Nov 02, 1989
ALCON SURGICAL SPONGE
K896004 · HOZ
Alcon Laboratories
Ophthalmic · 20d
Cleared Nov 02, 1989
MICROSPEARS
K896084 · HOZ
Sparta Surgical Corp.
Ophthalmic · 14d
Cleared Oct 31, 1989
DIATHRON(R) DIATHERMY UNIT
K894513 · HJM
Intl. Ophthalmic Industries Corp.
Ophthalmic · 104d
Cleared Oct 31, 1989
COBO TEMPORARY KERATOPROSTHESIS
K895013 · MLP
Ocular Instruments, Inc.
Ophthalmic · 84d