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
3289–3312 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · HPZ
Storz Instrument Co.
Ophthalmic · 21d
Cleared Mar 25, 1992
SUNGLASSES/READING GLASSES
K915263 · HQY
Royalking Industrial Corp.
Ophthalmic · 127d
Cleared Mar 19, 1992
AQUEOUS PARACENTESIS PIPET
K915808 · KYG
Visitec Co.
Ophthalmic · 86d
Cleared Mar 18, 1992
SUNGLASSES/READING GLASSES
K915605 · HQY
Royal Shine Enterprises, Ltd.
Ophthalmic · 93d
Cleared Mar 18, 1992
TECHNA SUN LENS
K915661 · HQY
Techna Intl.
Ophthalmic · 91d
Cleared Mar 13, 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · HQE
Storz Instrument Co.
Ophthalmic · 81d
Cleared Mar 11, 1992
OSTEO COMPRESSION HIP SCREW
K920037 · HRC
Osteo AG
Ophthalmic · 65d
Cleared Mar 11, 1992
SPECTACLE FRAME
K920170 · HQZ
Sciara Intl., Inc.
Ophthalmic · 58d
Cleared Mar 06, 1992
MEDILENS-CS CORNEAL SHIELD
K915861 · MOE
Chiron Ophthalmics
Ophthalmic · 66d
Cleared Mar 06, 1992
SPECTACLE FRAMES
K920123 · HQZ
Po-Le Optiks
Ophthalmic · 56d
Cleared Mar 04, 1992
OPTI-LENS CONTACT LENS CASE
K920064 · LRX
Ryder Intl. Corp.
Ophthalmic · 57d
Cleared Mar 02, 1992
RETINA TESTER
K914393 · HLX
Retina Tester
Ophthalmic · 153d
Cleared Mar 02, 1992
OPHTIMPLANT
K915630 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 76d
Cleared Mar 02, 1992
MAGNI-CAM
K920069 · HJG
Innoventions, Inc.
Ophthalmic · 55d
Cleared Feb 27, 1992
SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)
K914954 · HQZ
Jsu Corp.
Ophthalmic · 114d
Cleared Feb 27, 1992
S.A.A. EYE GLASS FRAMES
K915783 · HQZ
Yau Yee Optical Co., Ltd.
Ophthalmic · 65d
Cleared Feb 24, 1992
PHACO 20/20 SYSTEM I
K915457 · HQC
Innovative Medical Systems, Inc.
Ophthalmic · 81d
Cleared Feb 24, 1992
VISITEC CANALICULAR STENT
K915809 · LZU
Visitec Co.
Ophthalmic · 62d
Cleared Feb 21, 1992
STORZ MICRO CUTTER 25 GAUGE PACK
K913504 · HQE
Storz
Ophthalmic · 198d
Cleared Feb 21, 1992
OPACITRAC
K915356 · HJO
Oculon Corp.
Ophthalmic · 87d
Cleared Feb 19, 1992
OPTICAL FRAMES & SUNGLASSES
K914310 · HQY
Societe Nouvelle Idc
Ophthalmic · 147d
Cleared Feb 12, 1992
REGENCY, COMPARE, SUN OPTICS SUNGLASSES
K913419 · HQY
Cliff Weil, Inc.
Ophthalmic · 196d
Cleared Feb 12, 1992
PHACO 3000 LINEAR
K915456 · HQC
Innovative Medical Systems, Inc.
Ophthalmic · 69d
Cleared Feb 11, 1992
SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602
K913686 · HQY
Tel-Time Products
Ophthalmic · 176d