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
2521–2544 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 17, 1995
NON-PRESCRIPTION SUNGLASSES
K941266 · HQY
Gbs Corp.
Ophthalmic · 338d
Cleared Feb 17, 1995
NON-PRESCRIPTION SUNGLASSES
K941267 · HQY
Topstar Trading , Ltd.
Ophthalmic · 338d
Cleared Feb 14, 1995
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT
K941717 · HPZ
Miguel Martinez M.D.
Ophthalmic · 313d
Cleared Feb 14, 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · HQC
Storz Instrument Co.
Ophthalmic · 57d
Cleared Feb 13, 1995
OCUSYSTEM(ART)
K945583 · HQC
Arent Fox
Ophthalmic · 91d
Cleared Feb 08, 1995
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
K945171 · KYG
Boston Surgical Products, Inc.
Ophthalmic · 110d
Cleared Feb 07, 1995
KLAAS IOL LENSFOLDER
K930628 · KYB
Bova Intl.
Ophthalmic · 729d
Cleared Feb 07, 1995
METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO,...
K945680 · HQY
Solex Marketing, Inc.
Ophthalmic · 78d
Cleared Feb 07, 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE
K945762 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Feb 07, 1995
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
K945763 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Feb 07, 1995
ROSE K LENS
K945955 · HQD
Rose K International , Ltd.
Ophthalmic · 63d
Cleared Feb 07, 1995
LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS
K945981 · LPL
Permeable Technologies, Inc.
Ophthalmic · 61d
Cleared Feb 07, 1995
COLLAGEN INTRACANALICULAR PLUG
K946357 · LZU
Oasis Medical, Inc.
Ophthalmic · 39d
Cleared Feb 07, 1995
SUNGLASSES
K950079 · HQY
Gianni Versace
Ophthalmic · 28d
Cleared Feb 07, 1995
LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
K950283 · LPL
Permeable Technologies, Inc.
Ophthalmic · 14d
Cleared Feb 03, 1995
60 FUNDUS CAMERA CF-60UV
K946058 · HKI
Canon USA, Inc.
Ophthalmic · 87d
Cleared Feb 01, 1995
SUNGLASSES AND SPORT SUNGLASSES
K945528 · HQY
Lily & Assoicates, Inc.
Ophthalmic · 79d
Cleared Jan 31, 1995
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
K945382 · HLQ
Expertech Assoc., Inc.
Ophthalmic · 90d
Cleared Jan 31, 1995
FI, GORDY TOY, WELLJOY AND OTHERS
K946004 · HQY
Fundamental Industrial Co., Ltd.
Ophthalmic · 53d
Cleared Jan 31, 1995
AVON SUNNY DAYS SUNGLASSES
K946091 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 48d
Cleared Jan 31, 1995
AVON SUNNY DAYS SUNGLASSES
K946092 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 48d
Cleared Jan 30, 1995
OPHTHALMIC CAUTERY
K945493 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Jan 24, 1995
DATEMINDER CONTACT LENS CASE
K945259 · LRX
Bruce A. Berkley
Ophthalmic · 88d
Cleared Jan 24, 1995
PRECISION UV(TM) (VASURFICON A)
K946012 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 43d