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
2041–2064 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Jun 26, 1997
SPECTACLE FRAMES (NON-PRESCRIPTION)
K972246 · HQY
Alimar Trading, Inc.
Ophthalmic · 10d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · MPA
Ophthalmic Technologies, Inc.
Ophthalmic · 49d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · MPA
American Medical Devices, Inc.
Ophthalmic · 106d
Cleared Jun 24, 1997
CEBE
K971644 · HQY
Suunto USA
Ophthalmic · 50d
Cleared Jun 24, 1997
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K971685 · HKI
Tomey Corporation USA
Ophthalmic · 48d
Cleared Jun 24, 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014 · HQY
Tamfort, Ltd.
Ophthalmic · 25d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194 · HQY
Riviera Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · MML
Ipax, Inc.
Ophthalmic · 78d
Cleared Jun 17, 1997
BLOOD FLOW ANALYZER
K970887 · HKY
Paradigm Medical Industries, Inc.
Ophthalmic · 98d