Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

QAS 2020-06-24

CINA

Applicant Avicenna.Ai

K-Number K200855

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OWB 2020-06-24

ControlRad Trace Model 9

Applicant Controlrad, Inc.

K-Number K200663

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FET 2020-06-23

Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525

Applicant Richard Wolf Medical Instruments Corporation

K-Number K200617

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EBF 2020-06-23

VarseoSmile Crown plus

Applicant Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

K-Number K201668

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FCX 2020-06-23

CO2mbiLED

Applicant Karl Storz Endoscopy America, Inc.

K-Number K201096

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LFL 2020-06-23

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K200774

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PNN 2020-06-23

ULab Systems uDesign Software

Applicant Ulab Systems, Inc.

K-Number K200772

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QIH 2020-06-23

LVivo Software Application

Applicant Dia Imaging Analysis, Ltd.

K-Number K200232

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OMC 2020-06-22

Byteflies Kit

Applicant Byteflies NV

K-Number K192549

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MSD 2020-06-22

GlidePath 10F Long-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K-Number K200627

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JOW 2020-06-22

Zeroveno

Applicant Dimedi Co., Ltd.

K-Number K192337

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IRP 2020-06-22

Air Compression Therapy System

Applicant Shenzhen Lifotronic Technology Co., Ltd.

K-Number K192466

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