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
4681–4704 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 16, 1983
MEDIC LUX DIAGNOSTIC SETS
K832437 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Aug 16, 1983
POLYCORE
K832461
Polycore Optical Pte , Ltd.
Ophthalmic · 21d
Cleared Aug 16, 1983
OCULOPRESSOR
K832477
Hans Gevder
Ophthalmic · 21d
Cleared Aug 12, 1983
BAILEY ASPIRATOR/IRRIGATOR
K831584 · HQE
Medical Instrument Development...
Ophthalmic · 87d
Cleared Aug 12, 1983
ELECTRIC INSTRUMENT TABLE
K832073 · HMF
CooperVision, Inc.
Ophthalmic · 45d
Cleared Aug 12, 1983
SNO STRIPS STERILE TEARFLOW TEST STRIP
K832181 · KYD
Smith & Nephew, Inc.
Ophthalmic · 37d
Cleared Aug 01, 1983
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074 · HKP
CooperVision, Inc.
Ophthalmic · 34d
Cleared Aug 01, 1983
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · HPT
CooperVision, Inc.
Ophthalmic · 27d
Cleared Jul 18, 1983
FLUORETS STERILE OPHTH. STRIPS
K831621 · KYC
Smith & Nephew, Inc.
Ophthalmic · 60d
Cleared Jul 12, 1983
OCULAR IRRIGATING CANNULA
K831532 · HMX
Dey Laboratories, Inc.
Ophthalmic · 60d
Cleared Jul 12, 1983
UNIVERSAL PACK
K831701 · HQC
Atlantic Optical Systems, Inc.
Ophthalmic · 48d
Cleared Jul 12, 1983
LACIMAL INTUBATION SETS
K831901 · HNL
Visitec Co.
Ophthalmic · 28d
Cleared Jul 12, 1983
DISPOSABLE CYSTOTOME
K831916 · HNY
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jul 12, 1983
MICRO SURGICAL HANDLE
K831996 · KYG
Visitec Co.
Ophthalmic · 21d
Cleared Jun 30, 1983
SUN PHOTO-KERATOSCOPE
K831084 · HLQ
Nidek, Inc.
Ophthalmic · 87d
Cleared Jun 30, 1983
INFUSION CANNULA
K831192 · HMX
Medical Instrument Development...
Ophthalmic · 79d
Cleared Jun 30, 1983
SCLERAL PLUG
K831193 · LXP
Medical Instrument Development...
Ophthalmic · 79d
Cleared Jun 30, 1983
RARE-EARTH INTRA-OCULAR MAGNET
K831702 · HPN
Miami Eye Technology, Inc.
Ophthalmic · 36d
Cleared Jun 30, 1983
EPSILON ULTRASONIC TIP
K831836 · HQC
CooperVision, Inc.
Ophthalmic · 23d
Cleared Jun 10, 1983
EYELID SPECULUM
K830430 · HNC
Douglas C. Mckee & Co.
Ophthalmic · 121d
Cleared Jun 10, 1983
LENSERT CONTACT LENS CLEANING & INSERT
K830738 · KYE
Jermyn Specialties of California
Ophthalmic · 94d
Cleared Jun 10, 1983
AUTO REFRACTOMETER
K831083 · HKO
Nidek, Inc.
Ophthalmic · 67d
Cleared Jun 10, 1983
MICROSURGICAL KNIFE
K831266 · HNN
Vxtra Corp.
Ophthalmic · 53d
Cleared Jun 08, 1983
ALPHAMEDIX I/A HAND-PIECE, 500-001
K830812 · HQC
Alphamedix, Inc.
Ophthalmic · 85d