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
1753–1776 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Nov 24, 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT...
K992264 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 141d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV...
K993252 · MVN
CooperVision, Inc.
Ophthalmic · 57d
Cleared Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR...
K990292 · HQE
Ophthalmic Consultants, Inc.
Ophthalmic · 294d
Cleared Nov 18, 1999
COLORMAX COLOR VISION ENHANCEMENT LENSES
K984219 · NAI
Color Vision Technologies, Inc.
Ophthalmic · 358d
Cleared Nov 18, 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
K992950 · LPL
Prosthetic Soft Lens Corp.
Ophthalmic · 78d
Cleared Nov 16, 1999
RICROKERATOME BLADE
K992978 · HNO
Surgistar, Inc.
Ophthalmic · 74d
Cleared Nov 09, 1999
SL990, SL980, SL950
K992836 · HJO
Cso
Ophthalmic · 78d
Cleared Nov 02, 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR...
K991015 · LPL
Lamda Polytech , Ltd.
Ophthalmic · 221d
Cleared Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
K991592 · HNI
KARL STORZ Endoscopy-America, Inc.
Ophthalmic · 179d