Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
2089–2112 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 20, 1997
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · HMX
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875 · MPA
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS...
K971515 · LPL
Biomed Devices Corp.
Ophthalmic · 25d
Cleared May 14, 1997
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
K965052 · LPL
Wesley Jessen Corp.
Ophthalmic · 147d
Cleared May 13, 1997
MBI ILLUMINATED RETINAL PICK
K964405 · MPA
M.B. Industries, Inc.
Ophthalmic · 190d
Cleared May 13, 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · MPA
M.B. Industries, Inc.
Ophthalmic · 181d
Cleared May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · HQY
Yeong Jiuh Corp.
Ophthalmic · 77d
Cleared May 13, 1997
SUNGLASSES
K971412 · HQY
Team Chien Industrial Co., Ltd.
Ophthalmic · 27d
Cleared May 09, 1997
TOMEY DTL ELECTRODE
K961805 · HLZ
Tomey Corporation USA
Ophthalmic · 364d
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