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

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176,076 results
56977–57000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2008
TETRIX CREAM
K071483 · FRO
Coria Laboratories, Ltd.
General & Plastic Surgery · 310d
Cleared Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
K072032 · MSV
Corgenix, Inc.
Immunology · 255d
Cleared Apr 04, 2008
WELLGRAFT PE II
K072170 · MQV
Gwowei Technology Co., Ltd.
Orthopedic · 242d
Cleared Apr 04, 2008
WELLGRAFT PE I
K072444 · MQV
Gwowei Technology Co., Ltd.
Orthopedic · 242d
Cleared Apr 04, 2008
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30,...
K072583 · DTR
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared Apr 04, 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K073364 · NKB
Depuy Spine, Inc.
Orthopedic · 126d
Cleared Apr 04, 2008
BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
K073458 · DZE
Btlock Srl
Dental · 116d
Cleared Apr 04, 2008
DENTIS DENTAL IMPLANT SYSTEM
K073486 · DZE
Dentis Co., Ltd.
Dental · 114d
Cleared Apr 04, 2008
VIZILITE EYEWEAR
K080043 · NXV
Zila, Inc.
Dental · 87d
Cleared Apr 04, 2008
VIVOSONIC NEUROSCREEN
K080060 · GWJ
Vivosonic, Inc.
Neurology · 86d
Cleared Apr 04, 2008
DENTAL UNIT WITH CHAIR
K080438 · EIA
North West Medical Instrument (Group)...
Dental · 45d
Cleared Apr 04, 2008
MODIFICATION TO: SAVI APPLICATOR KIT
K080565 · JAQ
Cianna Medical, Inc.
Radiology · 35d
Cleared Apr 04, 2008
KOWA GENESIS-D
K080681 · HKI
Kowa Co. , Ltd.
Ophthalmic · 25d
Cleared Apr 04, 2008
CRYOMINI
K080735 · GEX
Zimmer Elektromedizin GmbH
General & Plastic Surgery · 18d
Cleared Apr 04, 2008
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
K080806 · QEZ
Possis Medical, Inc.
Cardiovascular · 14d
Cleared Apr 04, 2008
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
K080827 · MSH
Handan Hengyong Protective & Clean...
General Hospital · 10d
Cleared Apr 03, 2008
MODEL D DISC FORCE
K073132 · ITH
North American Medical Corp (Nam)
Physical Medicine · 148d
Cleared Apr 03, 2008
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
K073483 · NXV
Den-Mat Holdings, LLC
Dental · 114d
Cleared Apr 03, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K073534 · GEX
Candela Corp.
General & Plastic Surgery · 108d
Cleared Apr 03, 2008
SPIRUS MEDICAL SURGICAL INSTRUMENT
K080042 · KMJ
Spirus Medical, Inc.
General Hospital · 86d
Cleared Apr 03, 2008
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
K080192 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 69d
Cleared Apr 03, 2008
LTM-T SURGICAL MESH
K080353 · FTL
Lifecell Corp.
General & Plastic Surgery · 52d
Cleared Apr 03, 2008
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
K080789 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 14d
Cleared Apr 02, 2008
SMART-ROD
K070584 · LHI
Duoject Medical Systems, Inc.
General Hospital · 398d