Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
1345–1368 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 30, 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
K041700 · LPL
Cantor & Nissel , Ltd.
Ophthalmic · 38d
Cleared Jul 23, 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · MXK
Bausch & Lomb
Ophthalmic · 106d
Cleared Jul 23, 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jul 16, 2004
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · HPZ
Porex Surgical, Inc.
Ophthalmic · 107d
Cleared Jul 13, 2004
INTELIPORT OCCLUDING DEVICE
K040231 · LZU
Alcon, Inc.
Ophthalmic · 162d
Cleared Jul 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
K041608 · LPL
Unilens Corp., USA
Ophthalmic · 22d
Cleared Jul 02, 2004
VARILUX VISIONPRINT SYSTEM (VPS)
K033949 · HLL
Essilor Intl.
Ophthalmic · 196d
Cleared Jun 23, 2004
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · HKI
Canon, Inc.
Ophthalmic · 14d
Cleared Jun 22, 2004
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
K041108 · MPA
Iscience Surgical Corporation
Ophthalmic · 55d
Cleared Jun 18, 2004
M3 MICROKERATOME
K032836 · HNO
Moria SA
Ophthalmic · 281d
Cleared Jun 17, 2004
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K040837 · MSS
Medicel AG
Ophthalmic · 78d
Cleared Jun 15, 2004
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC)...
K040900 · LPL
Optical Connection, Inc.
Ophthalmic · 70d
Cleared Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · KYB
Staar Surgical Co.
Ophthalmic · 310d
Cleared Jun 10, 2004
EYE SPHERE IMPLANTS
K040689 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 86d
Cleared May 27, 2004
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K040914 · LRX
Exero Products, Inc.
Ophthalmic · 49d
Cleared May 25, 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · HNO
Micro Specialties, Inc.
Ophthalmic · 208d
Cleared May 24, 2004
RTA MODEL D RETINAL THICKNESS ANALYZER
K041290 · HLI
Talia Technology , Ltd.
Ophthalmic · 11d
Cleared Mar 31, 2004
ONEUSE- PLUS MICROKERATOME
K040297 · HMY
Moria SA
Ophthalmic · 51d
Cleared Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 172d
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · HQD
Contamac, Ltd.
Ophthalmic · 127d
Cleared Mar 19, 2004
KERATO ANALYZER (EKA)
K040373 · NQE
Konan Medical, Inc.
Ophthalmic · 31d
Cleared Mar 12, 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL...
K033919 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Mar 08, 2004
PANORET, MODEL PNM 60
K040325 · HKI
Medibell Medical Vision Technologies...
Ophthalmic · 27d