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

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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FPA 2019-05-02

K-Shield Advantage Port Access Infusion Set (PAIS)

Applicant Kawasumi Laboratories, Inc.

K-Number K190233

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CFF 2019-05-02

HYDRASHIFT 2/4 daratumumab

Applicant Sebia

K-Number K190851

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GEX 2019-05-02

TRIO Handpiece

Applicant Omniguide, Inc.

K-Number K183199

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LXB 2019-05-02

Ponto 4

Applicant Oticon Medical AB

K-Number K190540

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