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

LZG 2016-10-25

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

Applicant Tandem Diabetes Care, Inc.

K-Number K162080

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KPS 2016-10-25

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162736

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MBI 2016-10-25

KATOR Suture Anchor

Applicant Kator, LLC

K-Number K162386

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LNH 2016-10-25

G-scan Brio, S-scan

Applicant Esaote, S.p.A.

K-Number K161973

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KLE 2016-10-25

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

Applicant Kuraray Noritake Dental, Inc.

K-Number K161042

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LLZ 2016-10-25

vRad PACS with Mammography

Applicant Virtual Radiologic Corporation

K-Number K162145

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MUJ 2016-10-25

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162370

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LJS 2016-10-25

PowerPICC Provena Catheters

Applicant C.R. Bard, Inc.

K-Number K162443

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LDF 2016-10-25

Tempo Temporary Pacing Lead

Applicant Biotrace Medical, Inc.

K-Number K160260

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MUD 2016-10-25

NIRO-200NX DP

Applicant Hamamatsu Photonics K.K.

K-Number K162117

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DSA 2016-10-24

Caremed patient cable and leadwires

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K153188

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LPL 2016-10-24

Visco (olifilcon A) soft contact lens

Applicant Visco Vision, Inc.

K-Number K160245

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