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
2089–2112 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · LPL
Ciba Vision Corporation
Ophthalmic · 70d
Cleared May 09, 1997
UNIKA
K971327 · HQY
Eyewear Partners Co.
Ophthalmic · 29d
Cleared May 06, 1997
EVEREST SUNGLASSES
K970315 · HQY
Ycc International Corp.
Ophthalmic · 99d
Cleared May 06, 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454 · HQY
Laxima Intl., Ltd.
Ophthalmic · 90d
Cleared May 06, 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476 · HQY
Hwa Mao Optical Co., Ltd.
Ophthalmic · 88d
Cleared May 06, 1997
REUSABLE VITRECTOMY PROBE
K970670 · HQE
Altex Vision
Ophthalmic · 71d
Cleared May 06, 1997
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · HQD
Polymer Technology Corp.
Ophthalmic · 70d
Cleared May 06, 1997
SOLAR SPECS
K970759 · HQY
Morris Rosenbloom & Co., Inc.
Ophthalmic · 64d
Cleared May 06, 1997
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
K970878 · MPA
American Medical Devices, Inc.
Ophthalmic · 57d
Cleared May 06, 1997
CUSTOM OPTICAL SUNGLASS FRAMES
K970895 · HQY
Custom Optical Frames, Inc.
Ophthalmic · 56d
Cleared May 06, 1997
BARAKKA, INFERNO, STERLING, AND/OR ONE
K970944 · HQY
Sentinal Importing Corp.
Ophthalmic · 54d
Cleared May 06, 1997
CLASSIC MATCH
K971104 · HQY
Delagar Division Belcam, Inc.
Ophthalmic · 41d
Cleared May 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
K971108 · MSG
Alexander Mfg. Co.
Ophthalmic · 41d
Cleared May 06, 1997
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN
K971249 · HQY
Andrew G. Halpern
Ophthalmic · 33d
Cleared May 06, 1997
ARROW COMPANY
K971326 · HQY
Excel Eyewear Corp.
Ophthalmic · 26d
Cleared May 06, 1997
SYNTEC, INC. DISPOSABLE BARE END FIBER
K971338 · MPA
Syntec, Inc.
Ophthalmic · 26d
Cleared May 05, 1997
DISPOSABLE VITRECTOMY PROBE
K970673 · HQE
Altex Vision
Ophthalmic · 70d
Cleared Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
K970033 · KYB
Alcon Laboratories
Ophthalmic · 110d
Cleared Apr 23, 1997
PUNCTUAL OCCLUDER
K970631 · LZU
Odyssey Medical, Inc.
Ophthalmic · 63d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501 · LZU
Lacrimedics, Inc.
Ophthalmic · 223d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963708 · LZU
Lacrimedics, Inc.
Ophthalmic · 210d
Cleared Apr 03, 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
K970095 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 83d
Cleared Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 89d
Cleared Apr 02, 1997
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
K970312 · LPL
Flexlens, Inc.
Ophthalmic · 65d