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

FLL 2019-05-05

Wireless Intelligent Thermometer

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K182437

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KNT 2019-05-04

Medline Quick-Clear Wand

Applicant Medline Industries, Inc.

K-Number K183577

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EBF 2019-05-03

CLEARFIL MAJESTY IC

Applicant Kuraray Noritake Dental, Inc.

K-Number K182430

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MAX 2019-05-03

HALF DOME Posterior Lumbar Interbody System

Applicant Astura Medical, LLC

K-Number K182877

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LRC 2019-05-03

RELIEVA ULTIRRA Sinus Balloon Catheter

Applicant Acclarent, Inc.

K-Number K190525

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EIE 2019-05-03

armor LC

Applicant Mavrik Dental Systems, Ltd.

K-Number K182118

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HTY 2019-05-03

Arthrex DynaNite® PIP (Hammertoe) Implant

Applicant Arthrex, Inc.

K-Number K190287

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KXE 2019-05-03

Aptis Medical Distal Radio Ulnar Joint Implant

Applicant Aptis Medical, LLC

K-Number K190599

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GXI 2019-05-03

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Applicant Relievant Medsystems

K-Number K190504

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HRS 2019-05-03

MatrixRIB Fixation System

Applicant DePuy Synthes

K-Number K190409

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MUU 2019-05-03

AuraGen 123 Suction Lipoplasty System (A123)

Applicant Auragen Aesthetics, LLC

K-Number K190278

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FGB 2019-05-03

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

Applicant Richard Wolf Medical Instruments Corporation

K-Number K183188

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