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
4297–4320 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 17, 1985
TECHNA VISION, INC.ELECTRIC TABLE
K853744 · HRJ
Techna Vision
Ophthalmic · 41d
Cleared Oct 15, 1985
THE FIELDMASTER MODEL 275
K852936 · HPT
Synemed, Inc.
Ophthalmic · 97d
Cleared Oct 15, 1985
COBURN I/A SYSTEM
K853457 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 60d
Cleared Oct 15, 1985
ORC ORACLE
K853668 · HLQ
Optical Radiation Corp.
Ophthalmic · 42d
Cleared Oct 15, 1985
ZEISS OPERATING KERATOMETER
K853723 · HLQ
Carl Zeiss, Inc.
Ophthalmic · 40d
Cleared Oct 15, 1985
ALL KINDS OF SUNGLASSES
K853921 · HQY
Winsburn Company , Ltd.
Ophthalmic · 22d
Cleared Oct 08, 1985
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
K853883 · HQC
Medical Corp. of America
Ophthalmic · 19d
Cleared Oct 04, 1985
RHODA-LUX LENS BLANKS
K850909 · HPX
Optatint, Inc.
Ophthalmic · 213d
Cleared Oct 04, 1985
LASERSAFE EYE SHIELDS
K852404 · HOY
Lasersafe, Inc.
Ophthalmic · 120d
Cleared Oct 04, 1985
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
K853308 · HQE
Frigitronics of Connecticut, Inc.
Ophthalmic · 58d
Cleared Oct 04, 1985
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM
K853358 · HMF
Dentsply Intl.
Ophthalmic · 53d
Cleared Oct 04, 1985
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K853382 · HQE
Mentor O & O, Inc.
Ophthalmic · 53d
Cleared Oct 04, 1985
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
K853790 · HQY
Rocky Mountain Medical Corp.
Ophthalmic · 24d
Cleared Oct 04, 1985
INDIRECT OPHTHALMOSCOPE
K853891 · HLJ
Carl Zeiss, Inc.
Ophthalmic · 15d
Cleared Sep 24, 1985
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · HQF
Visitec Co.
Ophthalmic · 102d
Cleared Sep 24, 1985
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
K853189 · HQC
Aesthetech Corp.
Ophthalmic · 56d
Cleared Sep 24, 1985
RELIANCE 1379
K853359 · HRJ
Dentsply Intl.
Ophthalmic · 43d
Cleared Sep 24, 1985
MICRON-SCOPE
K853499 · HNN
Magnum Diamond, Inc.
Ophthalmic · 35d
Cleared Sep 18, 1985
HUMPHREY FIELD ANALYZER MODEL 630
K852639 · HPT
Zeiss Humphrey System
Ophthalmic · 90d
Cleared Sep 11, 1985
ACUFEX COMPARATIVE SURGICAL KERATOMETER
K852424 · HJB
Acufex Microsurgical, Inc.
Ophthalmic · 96d
Cleared Sep 11, 1985
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · KYG
Visitec Co.
Ophthalmic · 41d
Cleared Sep 10, 1985
MARLIN SOFT LENS TWEEZER
K850983 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 10, 1985
MARLIN SOFT LENS HANDLER
K850984 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 06, 1985
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
K852953 · HLJ
Design Med. Corp.
Ophthalmic · 57d