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
1729–1752 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 25d
Cleared May 04, 2000
EYECAP IMAGING SYSTEM
K000368 · HKI
Clement Clarke Intl., Ltd.
Ophthalmic · 90d
Cleared May 02, 2000
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K000327 · HKO
Visx, Incorporated
Ophthalmic · 90d
Cleared Apr 28, 2000
OPTI-FREE EXPRESS LENS DROPS
K000385 · MRC
Alcon Universal, Ltd.
Ophthalmic · 81d
Cleared Apr 21, 2000
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 14d
Cleared Apr 20, 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Apr 19, 2000
BIOCERAMIC ORBITAL IMPLANT
K992294 · HPZ
Fci Ophthalmics, Inc.
Ophthalmic · 287d
Cleared Apr 17, 2000
FLUROPERM 60-OK, PARAGON HDS-OK
K000224 · MUW
Paragon Vision Sciences
Ophthalmic · 84d
Cleared Apr 17, 2000
SUTUREGROOVE
K994289 · MML
Iop, Inc.
Ophthalmic · 118d
Cleared Apr 14, 2000
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
K993489 · LPL
Crystal Reflections, Int., Inc.
Ophthalmic · 182d
Cleared Apr 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 85d
Cleared Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · MRC
Alcon Laboratories
Ophthalmic · 84d
Cleared Apr 10, 2000
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
K000151 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 82d
Cleared Mar 31, 2000
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
K000731 · HLI
Talia Technology , Ltd.
Ophthalmic · 25d
Cleared Mar 23, 2000
REICHERT CT200 CONTACT TONOMETER
K000288 · HKY
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 52d
Cleared Mar 21, 2000
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY...
K000376 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared Mar 21, 2000
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT...
K000529 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 33d
Cleared Mar 20, 2000
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES,...
K000439 · LPL
Wesley Jessen Corp.
Ophthalmic · 39d
Cleared Mar 20, 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR...
K991840 · HKY
Bernard B. Fresco
Ophthalmic · 297d
Cleared Mar 20, 2000
BLADEWORKS MICROKERATOME BLADE
K993225 · HNO
Blade Works, Inc.
Ophthalmic · 175d
Cleared Mar 20, 2000
IOLMASTER
K993357 · HJO
Carl Zeiss, Inc.
Ophthalmic · 166d
Cleared Mar 20, 2000
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
K994335 · LPL
Wesley Jessen Corp.
Ophthalmic · 88d
Cleared Mar 16, 2000
MSP M/K BLADE
K993122 · HNO
Medical Sterile Products, Inc.
Ophthalmic · 178d
Cleared Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 110d