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
1369–1392 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 05, 2004
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
K033136 · LPL
Innova Vision, Inc.
Ophthalmic · 157d
Cleared Feb 20, 2004
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
K031774 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 256d
Cleared Feb 20, 2004
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · HJK
Dutch Ophthalmic Research Center...
Ophthalmic · 60d
Cleared Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · HQF
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Feb 04, 2004
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K033969 · LPL
Vistakon
Ophthalmic · 44d
Cleared Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · LPN
Ciba Vision Corporation
Ophthalmic · 77d
Cleared Feb 02, 2004
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K033656 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 73d
Cleared Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 121d
Cleared Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · HKX
Reichert, Inc.
Ophthalmic · 133d
Cleared Jan 13, 2004
SURGICAL MEDICAL DEVICE CAUTERY
K023506 · HQP
Modern Medical Equipment Mfg., Ltd.
Ophthalmic · 452d
Cleared Jan 13, 2004
MED-LOGICS, MODEL ML7090
K033293 · HNO
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
K031831 · HKO
Topcon Medical Systems, Inc.
Ophthalmic · 189d
Cleared Dec 17, 2003
VENTURI PHACO PACK
K033653 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 26d
Cleared Dec 15, 2003
EUSOL-C
K032422 · LYX
Al.Chi.Mi.A
Ophthalmic · 132d
Cleared Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY...
K033701 · MVN
Ciba Vision Corporation
Ophthalmic · 20d
Cleared Dec 12, 2003
AMNIOLENS
K032104 · NQB
Bio-Tissue, Inc.
Ophthalmic · 157d
Cleared Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · HKX
Nidek, Inc.
Ophthalmic · 183d
Cleared Dec 04, 2003
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
K032309 · LRX
Novelens, Inc.
Ophthalmic · 132d
Cleared Dec 04, 2003
VISION-TECH YZ SLIT LAMP, MODEL 66
K033190 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 64d
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598 · MPA
Synergetics, Inc.
Ophthalmic · 91d
Cleared Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 170d
Cleared Nov 14, 2003
PASCAL DYNAMIC CONTOUR TONOMETER
K032967 · HKY
Smt Swiss Microtechnology AG
Ophthalmic · 52d
Cleared Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · LPL
CooperVision, Inc.
Ophthalmic · 53d