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
2041–2064 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 31, 1997
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT...
K963744 · HQD
Benz Research and Development Corp.
Ophthalmic · 317d
Cleared Jul 31, 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC,...
K971832 · HOZ
M-Pact Worldwide Management Corp.
Ophthalmic · 73d
Cleared Jul 31, 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · HQY
Lbi U.S.A.
Ophthalmic · 20d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671 · HLI
Heidelberg Engineering
Ophthalmic · 83d
Cleared Jul 29, 1997
VISTA UNIVERSAL HANDPIECE
K972252 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
P3 UNIVERSAL PHACO HANDPIECE
K972253 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 25, 1997
D'ARC EYE CARE SUNGLASSES
K972490 · HQY
M & R Dist.
Ophthalmic · 23d
Cleared Jul 21, 1997
MOMO DESIGN OR MOMO
K972416 · HQY
Momo U.S.A., Inc.
Ophthalmic · 24d
Cleared Jul 15, 1997
CONFOCAL MICROSCOPE
K970414 · HJO
Con-S , Ltd.
Ophthalmic · 173d
Cleared Jul 15, 1997
LL BI-FOCAL, DAILY WEAR CONTACT LENS
K971647 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 71d
Cleared Jul 14, 1997
SUNGLASSES
K971385 · HQY
Kosway Industries Co., Ltd.
Ophthalmic · 91d
Cleared Jul 14, 1997
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · HQO
Mentor Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618 · LRX
Alcon Laboratories
Ophthalmic · 73d
Cleared Jul 14, 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 60d
Cleared Jul 14, 1997
FOVS, BRILLARTE, ETC...
K972362 · HQY
Sunglass City, Inc.
Ophthalmic · 19d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970318 · HQN
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970319 · HQN
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970320 · HQT
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970327 · HQT
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · HLJ
Alexander Mfg. Co.
Ophthalmic · 352d
Cleared Jul 01, 1997
(BRAND NAME)
K971384 · HQY
Long IN Time Ent. Co., Ltd.
Ophthalmic · 78d
Cleared Jul 01, 1997
SUNGLASSES
K971462 · HQY
D.G. Prove Co.
Ophthalmic · 71d
Cleared Jun 30, 1997
MEDPOR OCULAR SCREW AND ACCEOSSORIES
K971583 · MQU
Porex Technologies Corp.
Ophthalmic · 61d
Cleared Jun 30, 1997
WELCH ALLYN PHACO ILLUMINATOR
K971750 · HQC
Welch Allyn, Inc.
Ophthalmic · 49d