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
1369–1392 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Nov 04, 2003
THERATEARS CONTACT LENS COMFORT DROPS
K032481 · LPN
Advanced Vision Research, Inc.
Ophthalmic · 84d
Cleared Nov 04, 2003
COLIBRI DISPOSABLE VITRECTOMY CUTTER
K033390 · HQE
Microworld Medical Instruments, Inc.
Ophthalmic · 12d
Cleared Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978 · HNO
Ciba Vision Corporation
Ophthalmic · 26d
Cleared Oct 16, 2003
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
K032340 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 79d
Cleared Oct 10, 2003
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
K030910 · LPN
Clued UP Limited
Ophthalmic · 200d
Cleared Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 300d
Cleared Sep 25, 2003
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · MXK
Haag-Streit Holding AG
Ophthalmic · 232d
Cleared Sep 25, 2003
BLINK CL LUBRICANT EYE DROPS
K032030 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 86d
Cleared Sep 23, 2003
EYESOPEN TONOMETER
K032769 · HKY
Eye-Deas, LLC
Ophthalmic · 15d