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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35545–35568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2015
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR
K141460 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 291d
Cleared Mar 20, 2015
PROXIMAL HUMERUS PLATING SYSTEM
K141493 · HRS
Miami Device Solutions
Orthopedic · 288d
Cleared Mar 20, 2015
BIOMATE DENTAL IMPLANT SYSTEM
K142174 · DZE
Biomate Medical Devices Technology...
Dental · 225d
Cleared Mar 20, 2015
BT-400
K142332 · LBI
Bio-Med USA
General Hospital · 212d
Cleared Mar 20, 2015
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K142344 · HAW
Izi Medical Products, LLC
Neurology · 210d
Cleared Mar 20, 2015
F1-Modular Pedicle Screw System
K142531 · NKB
Degen Medical
Orthopedic · 192d
Cleared Mar 20, 2015
SonoFlow Sonohysterography and Sonohysterosalpingography Device
K142545 · LKF
Crossbay Medical, Inc.
Obstetrics & Gynecology · 191d
Cleared Mar 20, 2015
LM-9300 ELMA Lithotripter
K142561 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 190d
Cleared Mar 20, 2015
ONFLEX Mesh
K142711 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 179d
Cleared Mar 20, 2015
Fetal Doppler
K142769 · HEK
Icare Newlife Technologies, Inc.
Obstetrics & Gynecology · 176d
Cleared Mar 20, 2015
ARROW Reverse Shoulder long keel and short keel glenoid base
K142778 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 175d
Cleared Mar 20, 2015
Vyntus Walk
K142959 · DQA
Carefusion Germany 234 GmbH
Anesthesiology · 157d
Cleared Mar 20, 2015
LENSAR Laser System - fs 3D
K143010 · OOE
Lensar, Inc.
Ophthalmic · 151d
Cleared Mar 20, 2015
mDIXON XD
K143128 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 141d
Cleared Mar 20, 2015
Xenco Medical Lumbar Interbody System
K143158 · MAX
Xenco Medical, LLC
Orthopedic · 137d
Cleared Mar 20, 2015
myVision Track Model 005
K143211 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 130d
Cleared Mar 20, 2015
LnK Anterior Cervical Plate System
K143279 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 126d
Cleared Mar 20, 2015
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
K143313 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 121d
Cleared Mar 20, 2015
SurgiQuest AirSeal iFS System
K143404 · HIF
Surgiquest, Inc.
Obstetrics & Gynecology · 112d
Cleared Mar 20, 2015
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical...
K143626 · KWQ
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Mar 20, 2015
Navio
K143668 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 86d
Cleared Mar 20, 2015
RESTORIS POROUS PARTIAL KNEE SYSTEM
K150410 · HRY
Mako Surgical Corporation
Orthopedic · 30d
Cleared Mar 20, 2015
EOPA 3D Arterial Cannula
K150422 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Mar 20, 2015
Volcano iFR Modality, iFR Scout feature
K150441 · IYO
Volcano Corporation
Radiology · 28d