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
2065–2088 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · HQC
Storz Instrument Co.
Ophthalmic · 60d
Cleared Jun 13, 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · HQY
W.J. Byrnes & Co. of Los Angeles, Inc.
Ophthalmic · 80d
Cleared Jun 13, 1997
AMO DIPLOMAX/OPSYS CONSOLE
K971186 · HQC
Allergan, Inc.
Ophthalmic · 73d
Cleared Jun 13, 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · HQY
Niko Sunglasses Corp.
Ophthalmic · 38d
Cleared Jun 13, 1997
OPTIM-EYES 450
K971875 · HQY
Taylor/Fox Enterprises, LLC
Ophthalmic · 24d
Cleared Jun 09, 1997
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005 · MPA
Synergetics, Inc.
Ophthalmic · 275d
Cleared Jun 09, 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · HQC
Visioncare Devices, Inc.
Ophthalmic · 77d
Cleared Jun 05, 1997
GLARE WARE
K970816 · HQY
Ergovision, Inc.
Ophthalmic · 91d
Cleared Jun 04, 1997
DUQIAO
K971551 · HQY
Duqiao Glasses (Group) Co. , Ltd.
Ophthalmic · 37d
Cleared May 29, 1997
PATHFINDER SUNGLASSES
K971495 · HQY
Coil
Ophthalmic · 35d
Cleared May 28, 1997
KASHA VISUAL FIELD SYSTEM
K971156 · HPT
Kasha Software, Inc.
Ophthalmic · 61d
Cleared May 22, 1997
ML DISPOSABLE ALK TUBING
K971173 · KYG
Med-Logics, Inc.
Ophthalmic · 52d
Cleared May 21, 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K971049 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 61d
Cleared May 21, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K971164 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 51d
Cleared May 20, 1997
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
K964702 · MMQ
Euclid Systems Corp.
Ophthalmic · 176d
Cleared May 20, 1997
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · HMX
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875 · MPA
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS...
K971515 · LPL
Biomed Devices Corp.
Ophthalmic · 25d
Cleared May 14, 1997
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
K965052 · LPL
Wesley Jessen Corp.
Ophthalmic · 147d
Cleared May 13, 1997
MBI ILLUMINATED RETINAL PICK
K964405 · MPA
M.B. Industries, Inc.
Ophthalmic · 190d
Cleared May 13, 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · MPA
M.B. Industries, Inc.
Ophthalmic · 181d
Cleared May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · HQY
Yeong Jiuh Corp.
Ophthalmic · 77d
Cleared May 13, 1997
SUNGLASSES
K971412 · HQY
Team Chien Industrial Co., Ltd.
Ophthalmic · 27d
Cleared May 09, 1997
TOMEY DTL ELECTRODE
K961805 · HLZ
Tomey Corporation USA
Ophthalmic · 364d