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
2209–2232 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 22, 1996
GORE SPHEREX IMPLANT
K962241 · HPZ
W.L. Gore & Associates, Inc.
Ophthalmic · 72d
Cleared Aug 22, 1996
MARCELLA CARAN
K962912 · HQY
Framesmart, Inc.
Ophthalmic · 29d
Cleared Aug 22, 1996
FITO DIDO
K963075 · HQY
Framesmart, Inc.
Ophthalmic · 29d
Cleared Aug 15, 1996
NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
K960584 · HQD
Novavision, Inc.
Ophthalmic · 185d
Cleared Aug 14, 1996
EAGLE EYES SUNGLASSES
K962287 · HQY
Positive Response Television
Ophthalmic · 61d
Cleared Aug 06, 1996
STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
K961831 · HQC
Storz Instrument Co.
Ophthalmic · 85d
Cleared Aug 06, 1996
STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
K961874 · HQC
Storz Instrument Co.
Ophthalmic · 83d
Cleared Jul 25, 1996
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
K961820 · HQC
Storz Instrument Co.
Ophthalmic · 76d
Cleared Jul 25, 1996
READY-SET PUNCTAL PLUGS
K961909 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 70d
Cleared Jul 25, 1996
CENTER OPTICAL GLASSES
K962298 · HQY
Mirage Eyewear, Inc.
Ophthalmic · 42d
Cleared Jul 25, 1996
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
K962382 · HQY
Xiamen Chingsong Optical Industrial...
Ophthalmic · 35d
Cleared Jul 25, 1996
(BRAND NAME) SUNGLASS FRAMES
K962478 · HQY
Custom Optical Frames, Inc.
Ophthalmic · 30d
Cleared Jul 25, 1996
MODEL SL-YZ5E
K962522 · HJO
Pacific Ophthalmic Supply
Ophthalmic · 41d
Cleared Jul 25, 1996
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · HJO
Expertech Assoc., Inc.
Ophthalmic · 27d
Cleared Jul 25, 1996
SUNGLASSES, GAUDI SUN LINE
K962636 · HQY
Gaudi Spa
Ophthalmic · 20d
Cleared Jul 25, 1996
SOMA
K962725 · HQY
Soma International , Ltd.
Ophthalmic · 10d
Cleared Jul 25, 1996
SUNGLASSES (NON-PRESCRIPTION)
K962775 · HQY
Canadd Trading Co.
Ophthalmic · 9d
Cleared Jul 23, 1996
MEGATRON OPHTHALMIC SURGICAL SYSTEM
K961658 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 85d
Cleared Jul 23, 1996
CTM REUSABLE PAK
K962430 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 23, 1996
CTM DISPOSABLE PAK
K962431 · HQC
Circuit Tree Medical, Inc.
Ophthalmic · 29d
Cleared Jul 19, 1996
DIOPEXY PROBE
K960522 · HQF
Iriderm Div.
Ophthalmic · 164d
Cleared Jul 18, 1996
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · HKY
Clement Clarke, Inc.
Ophthalmic · 90d
Cleared Jul 15, 1996
MBI FIBEROPTIC ENDO-ILLUMINATOR
K961036 · MPA
M.B. Industries, Inc.
Ophthalmic · 123d
Cleared Jul 12, 1996
BOSTON CONTACT LENS CASE
K962512 · LRX
Polymer Technology Div. Wilmington...
Ophthalmic · 15d