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
4849–4872 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 13, 1981
PEARCE CORNEAL TREPHINE
K812723 · HRH
Visitec Co.
Ophthalmic · 15d
Cleared Oct 06, 1981
DI-CROWN
K812441 · HQG
Coburn Optical Ind., Inc.
Ophthalmic · 41d
Cleared Sep 21, 1981
SPECTACLE FRAMES
K810876 · HQZ
Fashionline Corp.
Ophthalmic · 174d
Cleared Sep 21, 1981
LENSINE EXTRA STRENGTH CLEANER
K812433 · HPX
CooperVision, Inc.
Ophthalmic · 27d
Cleared Sep 21, 1981
KOI DIAMOND KNIFE
K812450 · HNN
Koi, Inc.
Ophthalmic · 24d
Cleared Sep 21, 1981
RELIANCE OPHTHALMIC INSTRUMENT CONTROL
K812544 · HMF
F. & F. Koenigkramer
Ophthalmic · 17d
Cleared Sep 18, 1981
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · KYB
Biomet, Inc.
Ophthalmic · 92d
Cleared Sep 18, 1981
ULTRASONIC TIPS
K812126 · HQC
CooperVision, Inc.
Ophthalmic · 53d
Cleared Sep 08, 1981
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · HQG
American Optical Corp.
Ophthalmic · 49d
Cleared Aug 31, 1981
BARNES-HIND WEEKLY CLEANER
K812135 · HPX
Barnes-Hind, Inc.
Ophthalmic · 34d
Cleared Aug 31, 1981
CONTACT LENS CLEANER
K812172 · HPX
Alcon Laboratories
Ophthalmic · 32d
Cleared Aug 25, 1981
GLYCERINE DEHYDRATION UNIT
K810400
Xytex Corp.
Ophthalmic · 188d
Cleared Aug 20, 1981
DICON AUTO PERIMETER 200
K811346 · HPT
Dicon, Inc.
Ophthalmic · 100d
Cleared Aug 20, 1981
DICON AUTO PERIMETER 2000
K811347 · HPT
Dicon, Inc.
Ophthalmic · 100d
Cleared Aug 20, 1981
ETHICON LACRIMAL STENT
K812255 · HNL
Ethicon, Inc.
Ophthalmic · 8d
Cleared Aug 18, 1981
SR-1V DATA PRINTER
K812063 · HKO
American Optical Corp.
Ophthalmic · 28d
Cleared Aug 18, 1981
KOI LACREMAL HOOK & DILATOR
K812097 · HNW
Koi, Inc.
Ophthalmic · 25d
Cleared Aug 07, 1981
CROUCH CORNEAL PROTECTOR
K811577 · HOY
Denver Biomedicals, Inc.
Ophthalmic · 63d
Cleared Jul 31, 1981
OPHTHALMIC SCISSORS
K811245 · HNF
Keeler Instruments, Inc.
Ophthalmic · 88d
Cleared Jul 28, 1981
KOI LACRIMAL INTUBATION SYSTEM
K812010 · HMX
Koi, Inc.
Ophthalmic · 11d
Cleared Jul 28, 1981
BLADE GAUGE
K812011 · HOE
Koi, Inc.
Ophthalmic · 11d
Cleared Jul 16, 1981
EYE CARE TRAY
K811117
American Pharmaseal Div. Ahsc
Ophthalmic · 83d
Cleared Jul 02, 1981
BARNES-HIND SPECTACLE LENS CLEANER
K811554 · HQG
Barnes-Hind, Inc.
Ophthalmic · 30d
Cleared Jun 26, 1981
ANIS LENS IMPLANT FORCEPS #2
K811658 · HNR
American V. Mueller
Ophthalmic · 14d