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
1753–1776 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 09, 2000
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
K000544 · HJX
Labtician Ophthalmics, Inc.
Ophthalmic · 20d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 87d
Cleared Mar 02, 2000
HYLASHIELD CL
K994170 · MRC
Biomatrix, Inc.
Ophthalmic · 83d
Cleared Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY...
K994318 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY...
K994324 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 22, 2000
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · LYL
Strieter Clinical Research...
Ophthalmic · 88d
Cleared Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT...
K993190 · HNO
Surgical Instrument Systems (Sis), Ltd.
Ophthalmic · 140d
Cleared Feb 02, 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 167d
Cleared Feb 02, 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K993580 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 103d
Cleared Jan 31, 2000
ULTRASHAPER KERATOME
K990227 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 371d
Cleared Jan 20, 2000
CAUTERY GRASPER/DISSECTOR
K994019 · HQP
Starion Instruments
Ophthalmic · 55d
Cleared Jan 10, 2000
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · HKY
Automated Ophthalmics, Inc.
Ophthalmic · 125d
Cleared Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039 · MRH
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Jan 05, 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · MRC
Ciba Vision Corporation
Ophthalmic · 44d
Cleared Jan 04, 2000
TUBING EXTENSION SET
K993361 · MSR
Hurricane Medical
Ophthalmic · 90d
Cleared Dec 28, 1999
BLADEWORKS DISPOSABLE ALK TUBING
K993591 · KYG
Blade Works, Inc.
Ophthalmic · 67d
Cleared Dec 22, 1999
PARAGON LENS CARRIER
K993486 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 22, 1999
PARAGON LENS VIAL
K993487 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 21, 1999
KEELER CRYO MASTER & PROBES
K992954 · HRN
Keeler Instruments, Inc.
Ophthalmic · 111d
Cleared Dec 21, 1999
M-PACT CORNEAL LIGHT SHIELD
K993883 · HOZ
M-Pact Corp.
Ophthalmic · 36d
Cleared Dec 21, 1999
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES,...
K993935 · LPL
Wesley Jessen Corp.
Ophthalmic · 32d
Cleared Dec 10, 1999
ACTIFRESH 400 LENS
K983637 · LPL
Hydron , Ltd.
Ophthalmic · 420d
Cleared Dec 10, 1999
VIT ENHANCER
K992943 · HQE
Medical Instrument Development...
Ophthalmic · 101d