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
3481–3504 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 10, 1990
FRAME, SPECTACLE
K903949 · HQZ
Eureka Optics, Inc.
Ophthalmic · 13d
Cleared Aug 28, 1990
SUNGLASSES
K897090 · HQY
Pt Midas Surya Optical Co.
Ophthalmic · 251d
Cleared Aug 28, 1990
THE PRECISIONIST
K900493 · HQC
Paradigm Medical, Inc.
Ophthalmic · 207d
Cleared Aug 28, 1990
AUTOMATED HYDROSONICS(TM)
K902798 · HQC
Alcon Surgical, Inc.
Ophthalmic · 62d
Cleared Aug 28, 1990
TOY SUNGLASSES
K903202 · HQY
Creative Design
Ophthalmic · 39d
Cleared Aug 17, 1990
COLLAGEN SHIELD FOR ACUTE CARE
K902558 · MOE
Vitaphore Corp.
Ophthalmic · 67d
Cleared Aug 14, 1990
MODIFIED MOLTENO(TM) IMPLANTS
K902489 · KYF
Iop, Inc.
Ophthalmic · 90d
Cleared Aug 08, 1990
MAGIC HOT SHADES 70116, 70118, 70119
K902033 · HQY
Nationmark, Inc.
Ophthalmic · 96d
Cleared Aug 08, 1990
POLARON
K902187 · HPG
Nurion Industries
Ophthalmic · 86d
Cleared Aug 08, 1990
VISION JANTZEN SUNGLASSES
K902415 · HQY
Vision Products Co., Inc.
Ophthalmic · 69d
Cleared Aug 08, 1990
RUBBER SUNGLASSES
K902868 · HQY
Premium Source Merchandising
Ophthalmic · 40d
Cleared Aug 02, 1990
LAURENT TARDY
K903173 · HQZ
Acces Intl. Eyewear
Ophthalmic · 15d
Cleared Jul 31, 1990
VISI-DRAPE OPHTHALMIC DRAPES
K902857 · HMY
Visitec Co.
Ophthalmic · 32d
Cleared Jul 27, 1990
OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION
K900877 · HQY
Sunglass Originals, Inc.
Ophthalmic · 151d
Cleared Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
K902500 · HKO
Nidek, Inc.
Ophthalmic · 52d
Cleared Jul 26, 1990
VISI-SWAB OPHTALMIC SPONGE
K902750 · HOZ
Visitec Co.
Ophthalmic · 34d
Cleared Jul 24, 1990
FESAN SUNGLASSES
K902117 · HQY
Fesan, S.A.
Ophthalmic · 76d
Cleared Jul 24, 1990
SUNGLASSES
K902186 · HQY
Creative Paper Products, Inc.
Ophthalmic · 71d
Cleared Jul 24, 1990
LANDERS VITRECTOMY LENS RING W/INFUSION
K902496 · HNH
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Jul 20, 1990
SURG-K SURGICAL KERATOMETER
K901553 · HLR
The Sanborn Co.
Ophthalmic · 108d
Cleared Jul 19, 1990
TOY SUNGLASSES
K901802 · HQY
Sirco Intl. Corp.
Ophthalmic · 90d
Cleared Jul 17, 1990
OPTI-RAY SUNGLASSES
K902414 · HQY
Opti-Ray, Inc.
Ophthalmic · 47d
Cleared Jul 11, 1990
CLAS PHOTOKERATOSCOPE
K895741 · HLQ
Kera-Metrics Corp.
Ophthalmic · 288d
Cleared Jul 05, 1990
SUNGLASSES
K900944 · HQY
K Mart Apparel Corp.
Ophthalmic · 127d