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

FEB 2020-03-30

System 83 Plus Washer/Disinfector

Applicant Custom Ultrasonics, Inc.

K-Number K173590

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GAT 2020-03-30

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch

Applicant Teleflex Medical

K-Number K192490

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HGX 2020-03-30

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump

Applicant Guangzhou Yongyi Industrial Co., Ltd.

K-Number K192640

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MHX 2020-03-29

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES

Applicant GE Healthcare

K-Number K200494

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NGX 2020-03-29

Torc Body

Applicant Johari Digital Healthcare Limited

K-Number K192039

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DWF 2020-03-29

QuickDraw Venous Cannula

Applicant Edwards Lifesciences, LLC

K-Number K200499

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LNH 2020-03-28

MRI ECG Patient Cable

Applicant Ivy Biomedical Systems, Inc.

K-Number K192852

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KCT 2020-03-27

JJ Series Container System

Applicant Aesculap, Inc.

K-Number K192056

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NHJ 2020-03-27

BiWaze Cough

Applicant Abmrc, LLC

K-Number K191912

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KIF 2020-03-27

Diapaste

Applicant DiaDent Group International

K-Number K190091

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FTL 2020-03-27

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

Applicant Medtronic, Inc.

K-Number K192389

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LQK 2020-03-27

PregSense

Applicant Nuvo- Group , Ltd.

K-Number K191401

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