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
4321–4344 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 05, 1985
CONTACT LENS LOUPE, INSPETION LOUPE
K852054 · HLN
Ascon Medical Instruments, Ltd.
Ophthalmic · 119d
Cleared Sep 05, 1985
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000
K853149 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 6100
K853150 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 5000
K853151 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 04, 1985
ASCON OPHTHALMIC SPONGE
K852055 · HOZ
Ascon Medical Instruments, Ltd.
Ophthalmic · 118d
Cleared Sep 04, 1985
SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
K852386 · LPN
Barnes-Hind, Inc.
Ophthalmic · 91d
Cleared Sep 04, 1985
MST MODEL #ARLG-5
K853061
Marlo Surgical Technology
Ophthalmic · 47d
Cleared Aug 27, 1985
O.M.S. UV-COLOURS
K851410 · HQG
Optical Moulding Systems
Ophthalmic · 140d
Cleared Aug 21, 1985
OMS/GONVERS RETINAL PERFORATOR
K844448 · HNM
Optical Micro Systems, Inc.
Ophthalmic · 278d
Cleared Aug 20, 1985
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K851936 · HQE
Staar Surgical Co.
Ophthalmic · 106d
Cleared Aug 20, 1985
SITE-MALIS BIPOLAR COAGULATOR MODULE
K852075 · HQO
Valley Forge Scientific Corp.
Ophthalmic · 99d
Cleared Aug 20, 1985
PHACO-BAC STOP FILTER KIT
K852208 · HQC
Staar Surgical Co.
Ophthalmic · 91d
Cleared Aug 20, 1985
AURALITE II
K852403 · HQG
Aura Lens Products
Ophthalmic · 75d
Cleared Aug 20, 1985
OCULAB TONOPEN
K852774 · HKY
Oculab, Inc.
Ophthalmic · 50d
Cleared Aug 20, 1985
COOPER VISION SYSTEM VI U/S MODULE
K853070 · HQC
CooperVision, Inc.
Ophthalmic · 29d
Cleared Aug 20, 1985
INTEGRITY EYE DROP GUIDE(MODIFICATION)
K853199
Integrity Optics, Inc.
Ophthalmic · 20d
Cleared Aug 12, 1985
EFFNER-EYE CAUTERY WITH BATTERY HANDLE
K844775 · HQO
Mecron Medical Products, Inc.
Ophthalmic · 245d
Cleared Aug 12, 1985
OCULAR PRESSURE REDUCER (MCCANNEL)
K852032 · LCC
Visitec Co.
Ophthalmic · 95d
Cleared Aug 12, 1985
HUMPHREY IMAGE ANALYZER MODEL 110
K852638 · HKI
Zeiss Humphrey System
Ophthalmic · 53d
Cleared Aug 12, 1985
METALLIC SUNGLASSES
K852902 · HQY
Yours Enterprise Co., Ltd.
Ophthalmic · 34d
Cleared Aug 09, 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · HQE
CooperVision, Inc.
Ophthalmic · 73d
Cleared Aug 09, 1985
SPECTACLE PRESCRIPTION LENSES
K853110 · HQG
Ancie Laboratories
Ophthalmic · 16d
Cleared Aug 09, 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · HQE
Visitec Co.
Ophthalmic · 14d
Cleared Aug 08, 1985
SUNGLASSES
K852773 · HQY
Pony Industries Co., Ltd.
Ophthalmic · 44d