Search FDA 510(k) Database

6,920 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17353–17376 of 174,061
Cleared Sep 16, 2020
Ziehm Vision RFD 3D
K202360 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Sep 16, 2020
EOSedge
K202394 · KPR
Eos Imaging
Radiology · 26d
Cleared Sep 16, 2020
Butterfly iQ Ultrasound System
K202406 · IYN
Butterfly Network, Inc.
Radiology · 26d
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665 · PRH
Accelerate Diagnostics, Inc.
Microbiology · 356d
Cleared Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
K201170 · LIT
Boston Scientific Corporation
Cardiovascular · 137d
Cleared Sep 15, 2020
AcQMap 3D Imaging and Mapping Catheter
K201341 · MTD
Acutus Medical, Inc.
Cardiovascular · 118d
Cleared Sep 15, 2020
Massage Compression Boots
K201645 · IRP
Jkh USA, LLC
Physical Medicine · 90d
Cleared Sep 15, 2020
ARIX Elbow System
K201656 · HRS
Jeil Medical Corporation
Orthopedic · 89d
Cleared Sep 15, 2020
FIREBIRD SI Fusion System
K201664 · OUR
Orthofix, Inc.
Orthopedic · 88d
Cleared Sep 15, 2020
Collaboration Live
K201665 · LLZ
Philips Ultrasound, Inc.
Radiology · 88d
Cleared Sep 15, 2020
UNIFUSE Infusion System with Cooper Wire
K202347 · QEY
AngioDynamics, Inc.
Cardiovascular · 28d
Cleared Sep 14, 2020
VIVO
K200313 · DQK
Catheter Precision, Inc.
Cardiovascular · 221d
Cleared Sep 14, 2020
FusionFrame Ring Lock System
K200343 · KTT
Glw Medical Innovation
Orthopedic · 216d
Cleared Sep 14, 2020
Feelix Stethoscope
K200862 · DQD
Sonavi Labs, Inc.
Cardiovascular · 166d
Cleared Sep 14, 2020
VersaWrap Nerve Protector
K201631 · JXI
Alafair Biosciences, Inc.
Neurology · 90d
Cleared Sep 14, 2020
Shoreline ACS (Anterior Cervical System)
K201646 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Sep 14, 2020
Artus™ cervical plate system
K202227 · KWQ
Ulrich GmbH & Co. KG
Orthopedic · 38d
Cleared Sep 14, 2020
Marathon Flow Directed Micro Catheter
K202318 · KRA
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 28d
Cleared Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
K193657 · PNR
Shinva Ande Healthcare Apparatus Co.,...
Gastroenterology & Urology · 257d
Cleared Sep 11, 2020
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · MEG
Anhui Tiankang Medical Technology...
General Hospital · 450d
Cleared Sep 11, 2020
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
K192137 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 401d
Cleared Sep 11, 2020
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose...
K193340 · NBW
Microtech Medical, Inc.
Chemistry · 284d
Cleared Sep 11, 2020
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model...
K193449 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 273d
Cleared Sep 11, 2020
AMICUS Separator System
K200530 · GKT
Fresenius Kabi AG
Gastroenterology & Urology · 193d