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
4417–4440 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 20, 1985
CORNEASCOPE MODEL 1200
K850665 · HLQ
Kera Corp.
Ophthalmic · 28d
Cleared Mar 20, 1985
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
K850883 · HOZ
Storz Instrument Co.
Ophthalmic · 16d
Cleared Mar 20, 1985
CR-39 TYPE RESIN
K850905 · HQG
Orplex Corp.
Ophthalmic · 15d
Cleared Mar 13, 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · HQC
Visitec Co.
Ophthalmic · 188d
Cleared Mar 06, 1985
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA
K850049 · HNN
Xtal Corp.
Ophthalmic · 57d
Cleared Mar 05, 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · KYG
Jedmed Instrument Co.
Ophthalmic · 67d
Cleared Mar 04, 1985
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
K850191 · HPT
Bio-Rad
Ophthalmic · 45d
Cleared Feb 15, 1985
WHITE OCULAR PRESSURE RELIEF DEVICE
K840204 · KYF
Precision-Cosmet Co., Inc.
Ophthalmic · 393d
Cleared Feb 15, 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
K843596 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · HLI
Nidek, Inc.
Ophthalmic · 53d
Cleared Feb 14, 1985
CILCO I/A SURGICAL PACK
K843319 · HQC
Cilco, Inc.
Ophthalmic · 174d
Cleared Feb 14, 1985
DTL ELECTRODE
K844409 · HLZ
Sauquoit Industries, Inc.
Ophthalmic · 92d
Cleared Feb 06, 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · HQB
Cooper Lasersonics, Inc.
Ophthalmic · 98d
Cleared Jan 28, 1985
GRC-WT, GRC-W
K843899 · HKI
Olympus Corp.
Ophthalmic · 117d
Cleared Jan 22, 1985
TITMUS VISION TESTER II
K844694 · HIT
Titmus Optical, Inc.
Ophthalmic · 50d
Cleared Jan 22, 1985
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 56d
Cleared Jan 22, 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · HKI
Canon USA, Inc.
Ophthalmic · 36d
Cleared Jan 04, 1985
SUNGLASSES
K844778 · HQG
B & M Sporting Goods, Inc.
Ophthalmic · 25d
Cleared Jan 03, 1985
STEINWAY MICRO-KERATO-TREPHINE
K843646 · HRH
Steinway Instrument Co., Inc.
Ophthalmic · 108d
Cleared Jan 03, 1985
APPARATUS & METHODS SELF-EXAM OF EYE
K843702 · HOQ
Wheel Checkers
Ophthalmic · 104d
Cleared Jan 03, 1985
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
K844358 · HQF
Coherent Medical Group
Ophthalmic · 55d
Cleared Jan 03, 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 34d
Cleared Jan 03, 1985
MAGNIFYING SPECTACLES W/PLASTIC LENSES
K844716 · HOI
Gazelle Corp.
Ophthalmic · 30d