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
3529–3552 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 08, 1990
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K901686 · HQC
Nidek, Inc.
Ophthalmic · 57d
Cleared May 31, 1990
OCULAR INFUSION CANNULA SYSTEM
K901618 · HMX
Tamcenan Corp.
Ophthalmic · 55d
Cleared May 31, 1990
KESTREL LENS CASE (208-12NT POLYSTYRENE)
K901748 · LRX
Kestrel
Ophthalmic · 44d
Cleared May 30, 1990
MODEL 2000 INTRAOPERATIVE CORNEASCOPE
K901009 · HLQ
Kera Corp.
Ophthalmic · 86d
Cleared May 25, 1990
OCULAR OCCLUDER
K900942 · HOY
Microdynamics
Ophthalmic · 86d
Cleared May 25, 1990
TOPOGRAPHIC MODELING SYSTEM
K901363 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 63d
Cleared May 24, 1990
IM COLLAGEN SHIELD
K896449 · MOE
Intermedical, Inc.
Ophthalmic · 196d
Cleared May 24, 1990
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
K901309 · HJN
Sylvan Corp.
Ophthalmic · 65d
Cleared May 22, 1990
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
K901002 · HQX
Oculo Plastik, Inc.
Ophthalmic · 81d
Cleared May 21, 1990
OMNIPATCH
K900941 · HOY
Eye Garter Company, Inc.
Ophthalmic · 82d
Cleared May 18, 1990
VISI-SORB ABSORBANT STICK
K900786 · HOZ
Visitec Co.
Ophthalmic · 87d
Cleared May 18, 1990
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL
K900929 · HQX
Oculo Plastik, Inc.
Ophthalmic · 80d
Cleared May 15, 1990
CODERE-DURETTE ORBITAL FLOOR IMPLANT
K900927 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
COX MALAR EMINENCE IMPLANTS
K900928 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
K900930 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
SUNGLASSES
K901047 · HQY
Command Marketing Corp.
Ophthalmic · 70d
Cleared May 15, 1990
NON-PRESCRIPTION SUNGLASSES
K901168 · HQY
Renauld Intl. , Ltd.
Ophthalmic · 63d
Cleared May 15, 1990
CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES
K901299 · HQY
Sun Mark, Inc.
Ophthalmic · 56d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS
K900520 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
K900521 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
K900522 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
K900524 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS
K900526 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES
K900527 · HQY
J & B Assoc.
Ophthalmic · 90d