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
1297–1320 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 24, 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K043613 · HQF
Quantel Medical
Ophthalmic · 84d
Cleared Feb 25, 2005
THERMAL CAUTERY PROBE
K050308 · HQR
Starion Instruments
Ophthalmic · 17d
Cleared Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
K043222 · HKI
Carl Zeiss Meditec, AG
Ophthalmic · 84d
Cleared Feb 07, 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
K043236 · HQF
Quantel Medical
Ophthalmic · 77d
Cleared Feb 02, 2005
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
K040303 · LPL
Hydrogel Vision Corporation
Ophthalmic · 359d
Cleared Feb 01, 2005
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
K043540 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 41d
Cleared Jan 31, 2005
AMADEUS II EPIKERATOME
K043150 · HNO
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 77d
Cleared Jan 28, 2005
PACHYCAM
K041841 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 204d
Cleared Jan 25, 2005
I-PROMOTIONS CONTACT LENS CASE
K042578 · LRX
I-Promotions, Inc.
Ophthalmic · 125d
Cleared Jan 21, 2005
OCT-OPTHALMOSCOPE
K042885 · HLI
Ophthalmic Technologies, Inc.
Ophthalmic · 94d
Cleared Jan 12, 2005
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC...
K043129 · LPL
Opti-Centre Laboratories
Ophthalmic · 61d
Cleared Dec 28, 2004
CAPSULE TENSION RING INSERTER, MODEL 7-810
K042478 · NCE
Duckworth & Kent, Ltd.
Ophthalmic · 106d
Cleared Dec 10, 2004
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K042099 · HKX
Retinapharma Technologies, Inc.
Ophthalmic · 128d
Cleared Dec 09, 2004
STARION UNIVERSAL POWER SUPPLY (UPS)
K043155 · HQO
Starion Instruments
Ophthalmic · 24d
Cleared Nov 23, 2004
TONO-PEN TONOMETER TIP COVER
K033146 · HKY
Tra & Accessories
Ophthalmic · 420d
Cleared Nov 18, 2004
SELF RETAINING BICANALICULUS INTUBATION SET
K041869 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 132d
Cleared Nov 16, 2004
HYDROGEL CANALICULAR PLUG
K040912 · LZU
Partners IN Biomaterials, Inc.
Ophthalmic · 222d
Cleared Nov 16, 2004
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083 · HNO
Biovision AG
Ophthalmic · 105d
Cleared Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · LPL
CooperVision, Inc.
Ophthalmic · 35d
Cleared Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367 · HKI
Topcon Corp.
Ophthalmic · 165d
Cleared Nov 03, 2004
AQUIFY LENS COMFORT DROPS
K042176 · LPN
Ciba Vision Corporation
Ophthalmic · 84d
Cleared Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · LPN
Ciba Vision Corporation
Ophthalmic · 511d
Cleared Oct 28, 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
K042275 · LPL
Vistakon
Ophthalmic · 66d
Cleared Oct 28, 2004
CENTURION SES EPIKERATOME
K042810 · HNO
Norwood Abbey , Ltd.
Ophthalmic · 16d