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
2929–2952 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 01, 1994
SCMD KERATOME
K935342 · HNO
S.C.M.D. Keratomes of Arizona
Ophthalmic · 147d
Cleared Apr 01, 1994
MEGABEAM ENDOCULAR PROBE
K935747 · HQF
Ceram Optec, Inc.
Ophthalmic · 121d
Cleared Apr 01, 1994
SLIT LAMP, H-201
K936209 · HJO
Canon USA, Inc.
Ophthalmic · 93d
Cleared Mar 24, 1994
SUNGLASSES (NON-PERSCRIPTION)
K934567 · HQY
Jaan Huey Co., Ltd.
Ophthalmic · 189d
Cleared Mar 24, 1994
UNIVERSAL CUSHIONED METAL EYE SHIELD
K940213 · HOY
P.J. Products, Inc.
Ophthalmic · 69d
Cleared Mar 24, 1994
UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD
K940275 · HOY
P.J. Products, Inc.
Ophthalmic · 62d
Cleared Mar 24, 1994
ORVIS RIVER GUIDE GLASSES
K940292 · HQY
The Orvis Co., Inc.
Ophthalmic · 62d
Cleared Mar 24, 1994
ORVIS MARQUESAS FISHING GLASSES
K940354 · HQY
The Orvis Co., Inc.
Ophthalmic · 58d
Cleared Mar 14, 1994
360 DEGREE FIXATION LIGHT
K933739 · HPL
Varitronics
Ophthalmic · 223d
Cleared Mar 14, 1994
OPHTHALMIC SURGICAL SYSTEM
K935223 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 133d
Cleared Mar 14, 1994
SPORTS RADIO SUNGLASSES
K936027 · HQY
Vast Lea Enterprise Co. , Ltd.
Ophthalmic · 87d
Cleared Mar 07, 1994
STORZ FIBEROPTIC PICK MANIPULATOR
K933907 · HQE
Storz Instrument Co.
Ophthalmic · 208d
Cleared Mar 01, 1994
POST-MYDS(TM)
K930840 · HOY
Aukland Medical Plastics, Inc.
Ophthalmic · 377d
Cleared Mar 01, 1994
HGM ILLUMINATING IMAGING ENDOCULAR PROBE
K931784 · HQF
Hgm, Inc.
Ophthalmic · 326d
Cleared Mar 01, 1994
SPECTACLE FRAMES
K934570 · HQZ
Chaser Optical Corp.
Ophthalmic · 166d
Cleared Mar 01, 1994
MARTINEZ ORBITAL IMPLANT
K935251 · HPZ
Miguel Martinez M.D.
Ophthalmic · 120d
Cleared Mar 01, 1994
FOX EYE ALUMINUM SHIELD, OPHTHALMIC
K940095 · HOY
P.J. Products, Inc.
Ophthalmic · 53d
Cleared Mar 01, 1994
FRAME
K940312 · HQZ
Lanner Enterprise Co., Ltd.
Ophthalmic · 36d
Cleared Feb 25, 1994
SOPHER AND BIERER OVUM FORCEPS
K926540 · HLZ
Thomasville Medical Assoc.
Ophthalmic · 422d
Cleared Feb 25, 1994
KAMPPETER ANOMALOSCOPE
K930575 · HIW
Bova Intl.
Ophthalmic · 386d
Cleared Feb 25, 1994
SPECTACLE FRAME
K935920 · HQY
Cadore Moda USA, Inc.
Ophthalmic · 77d
Cleared Feb 23, 1994
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
K932668 · HQE
Synergetics, Inc.
Ophthalmic · 266d
Cleared Feb 22, 1994
SOLARSHIELD CLIPS
K925531 · HQY
Dioptics Medical Products, Inc.
Ophthalmic · 477d
Cleared Feb 22, 1994
P4000 PHACOEMULSIFIER
K931354 · HQC
American Optical Corp.
Ophthalmic · 342d