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
2425–2448 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 15, 1995
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
K951462 · HQC
Allergan Medical Optics
Ophthalmic · 77d
Cleared Jun 14, 1995
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)
K950077 · MMQ
Par Vision Systems Corp.
Ophthalmic · 155d
Cleared Jun 14, 1995
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
K952259 · HQC
Storz Instrument Co.
Ophthalmic · 30d
Cleared Jun 08, 1995
FIBER HEAD LIGHT FH-300
K951337 · HPQ
Neitz Instruments Company, Ltd.
Ophthalmic · 76d
Cleared Jun 07, 1995
NON-MYDRIATIC RETINAL CAMERA
K941234 · HKI
Canon USA, Inc.
Ophthalmic · 449d
Cleared Jun 07, 1995
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · HJM
Peregrine Surgical , Ltd.
Ophthalmic · 120d
Cleared Jun 06, 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · HLI
Welch Allyn, Inc.
Ophthalmic · 81d
Cleared Jun 06, 1995
FAIRY WORLD INC
K951992 · HQY
Fairy World, Inc.
Ophthalmic · 39d
Cleared Jun 02, 1995
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · HQC
Storz Instrument Co.
Ophthalmic · 142d
Cleared Jun 02, 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · KYB
Chiron Vision Corp.
Ophthalmic · 72d
Cleared May 30, 1995
CUSTOM ARTIFICIAL HUMAN EYES
K945270 · HQH
Daniel T Acosta
Ophthalmic · 214d
Cleared May 30, 1995
DIGITAL RETINOSCOPIC PHOTOMETER
K951179 · HKO
Kudi Kalu, Inc.
Ophthalmic · 75d
Cleared May 26, 1995
SPECTACLE SUN GLASSES
K940324 · HQY
Occhiali, International Eyewear
Ophthalmic · 487d
Cleared May 26, 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · HQC
American Optical Corp.
Ophthalmic · 88d
Cleared May 24, 1995
SUNBLOCKER SUNGLASSES
K950807 · HQY
Blublocker Corp.
Ophthalmic · 91d
Cleared May 22, 1995
POSTERIOR CAPSULE SHIELD
K950798 · HQC
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared May 22, 1995
PRO-PAK FOR OMS DIPLOMATE
K950800 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 90d
Cleared May 19, 1995
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
K950852 · HQE
H.S. Intl. Co., Inc.
Ophthalmic · 81d
Cleared May 16, 1995
RYDER CONTACT LENS CASE MODEL 10670
K951182 · LRX
Bradstreet Clinical Research Assoc.,...
Ophthalmic · 61d
Cleared May 12, 1995
NON-CONTACT TONOMETER T-2
K943939 · HKX
Canon, Inc.
Ophthalmic · 273d
Cleared May 12, 1995
CRYSTAL
K951168 · HQY
Crystal Optical Co., Ltd.
Ophthalmic · 58d
Cleared May 12, 1995
RYDER CONTACT LENS CASE
K951181 · LRX
Bradstreet Clinical Research Assoc.,...
Ophthalmic · 57d
Cleared May 12, 1995
OTI MODEL 78-60
K951184 · HJO
Oti Medical, LLC
Ophthalmic · 57d
Cleared May 12, 1995
FMS HIGH FLOW ARTHRO-SHEATH
K951702 · HNX
Future Medical Systems, Inc.
Ophthalmic · 30d