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
3961–3984 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 27, 1987
FH LEN
K872503 · HQY
Fu Heng First Industrial Co., Ltd.
Ophthalmic · 33d
Cleared Jul 27, 1987
MELANITE I
K872506 · HQG
Aura Lens Products
Ophthalmic · 33d
Cleared Jul 27, 1987
TAPELESS EYE SHIELD
K872659 · HOY
Precision Therapeutics, Inc.
Ophthalmic · 20d
Cleared Jul 22, 1987
EASY EYES TM LENS CARRYING CASE
K871741 · LRX
Eaton Medical Corp.
Ophthalmic · 78d
Cleared Jul 21, 1987
EYE GARD
K872000 · HOY
Treace Medical, Inc.
Ophthalmic · 56d
Cleared Jul 15, 1987
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
K872312 · HQE
Allergan Humphrey
Ophthalmic · 92d
Cleared Jun 25, 1987
HAMACHER BULLET POINT OPHTHALMIC NEEDLE
K872200 · HMX
R. J. Doyle, Inc.
Ophthalmic · 17d
Cleared Jun 25, 1987
COOL SHADES
K872218 · HQY
Mattel, Inc.
Ophthalmic · 16d
Cleared Jun 19, 1987
MORGAN THERAPEUTIC LENS
K871454 · KYG
Mortan, Inc.
Ophthalmic · 67d
Cleared Jun 19, 1987
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 56d
Cleared Jun 19, 1987
CANON SURGICAL AUTO KERATOMETER SK-1
K871936 · HLQ
Canon USA, Inc.
Ophthalmic · 32d
Cleared Jun 19, 1987
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
K872136 · HJK
Ocular Instruments, Inc.
Ophthalmic · 16d
Cleared Jun 19, 1987
OPHTHALMIC CANNULA
K872151 · HMX
Pharmacia, Inc.
Ophthalmic · 15d
Cleared Jun 12, 1987
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Jun 12, 1987
EYEDENTITY EYEWEAR
K872062 · HQZ
Vitech Research C/O Johnsen, Manfredi...
Ophthalmic · 15d
Cleared Jun 11, 1987
SUMMIT OPTICS POST-MYDRIATIC SPECTACLES
K871800 · HQY
Summit Optics, Inc.
Ophthalmic · 34d
Cleared Jun 11, 1987
SERIES TEN THOUSAND OCUTOME
K871871 · HQE
CooperVision, Inc.
Ophthalmic · 29d
Cleared Jun 10, 1987
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K871268 · HLI
G. Rodenstock Instrumente GmbH
Ophthalmic · 71d
Cleared Jun 03, 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
K871450 · HJK
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Jun 03, 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 49d
Cleared Jun 03, 1987
VOROSCOPE(TM)
K871735 · HLJ
Australian Biomedical Corporation , Ltd.
Ophthalmic · 29d
Cleared Jun 03, 1987
T P C (TONOMETER PROBE COVER)
K871935 · HKX
Krb Ent.
Ophthalmic · 15d
Cleared Jun 03, 1987
MULTIPLE SPECTACLE LENS
K871961 · HQG
Korea Asahi Optical Co., Ltd.
Ophthalmic · 14d
Cleared May 29, 1987
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K870807 · HNO
Allergan, Inc.
Ophthalmic · 91d