Search FDA 510(k) Database

6,946 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17881–17904 of 174,061
Cleared Jul 10, 2020
Ezra Plexo Software
K192969 · QIH
Ezra Ai, Inc.
Radiology · 261d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d
Cleared Jul 10, 2020
AI-Rad Companion Engine
K193294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 226d
Cleared Jul 10, 2020
NextAR TKA Platform
K193559 · SBF
Medacta Inernational SA
Orthopedic · 200d
Cleared Jul 10, 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 197d
Cleared Jul 10, 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · OLO
Globus Medical, Inc.
Neurology · 183d
Cleared Jul 10, 2020
Infrascanner
K200203 · OPT
Infrascan, Inc.
Neurology · 164d
Cleared Jul 10, 2020
Pelvital System
K200409 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 142d
Cleared Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
K200427 · LFL
Covidien, LLC
General & Plastic Surgery · 140d
Cleared Jul 10, 2020
X-Cube 90
K200449 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
X-Cube 70
K200450 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
K200480 · BZD
Respironics, Inc.
Anesthesiology · 134d
Cleared Jul 10, 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 128d
Cleared Jul 10, 2020
SmartLinx Vitals Plus Patient Monitoring System
K200856 · MWI
Capsule Technologie Sas
Cardiovascular · 100d
Cleared Jul 10, 2020
Disposable Specimen Retrieval Bag
K201243 · GCJ
Beijing Biosis Healing Biolog Ical...
General & Plastic Surgery · 63d
Cleared Jul 10, 2020
ASSISTO Universal Applicator Clamping Device
K201279 · JAQ
Geomed Medizin-Technik GmbH & Co. KG
Radiology · 58d
Cleared Jul 10, 2020
HD Steth
K201299 · DQD
Hd Medical, Inc.
Cardiovascular · 56d
Cleared Jul 10, 2020
Triathlon Total KneeSystem
K201343 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Jul 10, 2020
Resoundant Acoustic Driver System
K201389 · LNH
Resoundant, Inc.
Radiology · 44d
Cleared Jul 10, 2020
Eclipse Treatment Planning System v16.1
K201607 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 10, 2020
DigitalDiagnost C50
K201725 · KPR
Philips Healthcare (Suzhou) Co., Lit.
Radiology · 17d
Cleared Jul 09, 2020
Optiflux Enexa F500 Dialyzer
K192928 · KDI
Fresenius Medical Care Reanal...
Gastroenterology & Urology · 266d
Cleared Jul 09, 2020
GC Temp Print
K193113 · EBG
GC America, Inc.
Dental · 240d
Cleared Jul 09, 2020
GTK Trocars
K193272 · GCJ
Guangzhou T.K Medical Instrument Co.,...
General & Plastic Surgery · 226d