Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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PQW 2019-05-03

NeoLSD MSMS Kit

Applicant Perkinelmer, Inc.

K-Number K190266

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PGW 2019-05-03

TruDi NAV Wire

Applicant Acclarent, Inc.

K-Number K190532

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HQF 2019-05-03

Leaf Photocoagulator

Applicant Norlase Aps

K-Number K190083

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PMN 2019-05-03

FilmArray Pneumonia/Pneumoniaplus Control

Applicant Maine Molecular Quality Controls, Inc.

K-Number K190222

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IOR 2019-05-03

Manual Wheelchair W54

Applicant Jiangsu Jumao Medical Equipment Co., Ltd.

K-Number K180309

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DFH 2019-05-03

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K190879

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JFJ 2019-05-02

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

Applicant Biosystems S.A.

K-Number K182474

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MUD 2019-05-02

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

Applicant Nonin Medical, Inc.

K-Number K190560

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