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
2329–2352 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 06, 1995
KUO & YANG SUNGLASSES
K955290 · HQY
Kuo & Yang Industrial Co., Ltd.
Ophthalmic · 19d
Cleared Dec 01, 1995
OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED
K952620 · LPL
Benz Research and Development Corp.
Ophthalmic · 178d
Cleared Dec 01, 1995
EVOLUTION PHACOMULSIFIER
K954240 · HQC
U.S. Iol, Inc.
Ophthalmic · 81d
Cleared Dec 01, 1995
SURGIN GENISIS PHACOEMULSIFIER
K954241 · HQC
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 81d
Cleared Dec 01, 1995
CIRCUIT TREE PHACOEMULSIFIER
K954242 · HQC
Circuit Tree
Ophthalmic · 81d
Cleared Dec 01, 1995
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
K954780 · HKI
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Dec 01, 1995
KOWA GENESIS HAND-HELD FUNDUS CAMERA
K954781 · HKI
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Nov 24, 1995
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Nov 24, 1995
HUMPHREY FIELD ANALYZER (HFA II)
K954167 · HPT
Carl Zeiss, Inc.
Ophthalmic · 80d
Cleared Nov 24, 1995
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
K954782 · HJO
Kowa Optimed, Inc.
Ophthalmic · 38d
Cleared Nov 17, 1995
LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55...
K951893 · LPL
Permeable Technologies, Inc.
Ophthalmic · 207d
Cleared Nov 17, 1995
PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT...
K953959 · HQC
Microsurgical Technology, Inc.
Ophthalmic · 87d
Cleared Nov 17, 1995
ANGIOVISION VIEWING STATION
K953972 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Nov 17, 1995
ANGIOVISION 1000
K953973 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Nov 17, 1995
FIELD TREND
K954037 · HPT
Synemed, Inc.
Ophthalmic · 81d
Cleared Nov 06, 1995
BARRAQUER-KRUMEICH REFRACTIVE SET
K954058 · HNO
Eyetech M.V.A.
Ophthalmic · 154d
Cleared Oct 27, 1995
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE
K950869 · LRX
Jobar Intl., Inc.
Ophthalmic · 242d
Cleared Oct 27, 1995
STORZ I/A HANDPIECES
K951463 · HQC
Storz Instrument Co.
Ophthalmic · 211d
Cleared Oct 25, 1995
DRIVING GLASSES
K951757 · HQY
Proview Optical Group Corp.
Ophthalmic · 191d
Cleared Oct 25, 1995
NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
K953627 · HQY
New Sun Optical Enterprise Co., Ltd.
Ophthalmic · 86d
Cleared Oct 25, 1995
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES
K953744 · HQY
Amita Corp.
Ophthalmic · 93d
Cleared Oct 25, 1995
CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES
K953808 · HQY
Cheng Chen Hsing Enterp. & Fact. Co....
Ophthalmic · 79d
Cleared Oct 25, 1995
SINCLAIR NON-PRESCRIPTION SUNGLASSES
K954393 · HQY
Sinclair Corp.
Ophthalmic · 37d
Cleared Oct 25, 1995
BLINDE OPTICS
K954636 · HQY
Blinde Eyewear, Inc.
Ophthalmic · 19d