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

LLZ 2017-02-06

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163294

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PRA 2017-02-06

Variola virus Real-Time PCR Assay

Applicant Centers For Disease Control and Prevention (CDC)

K-Number DEN160016

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DQA 2017-02-06

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

Applicant Bluepoint Medical GmbH & Co. KG

K-Number K162014

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EMA 2017-02-06

3M Protemp Cement Temporary Dental Cement

Applicant 3M Company

K-Number K170330

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NXC 2017-02-03

MTM Clear Aligner

Applicant Dentsply Sirona

K-Number K163155

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LJS 2017-02-03

PICC Maximal Barrier Nursing Kit

Applicant Navilyst Medical, Inc.

K-Number K163452

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GZI 2017-02-03

RehaStim 2

Applicant Hasomed GmbH

K-Number K162683

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MHX 2017-02-03

Telemetry Transmitter

Applicant Edan Instruments, Inc.

K-Number K161056

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HRS 2017-02-03

AxSOS 3 Ti; Stryker Plating System

Applicant Stryker GmbH

K-Number K162439

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NFO 2017-02-03

Micro-current Wrinkle Reduction Facial service, model EP-400

Applicant Li-Tek Electronic Technology Corporation

K-Number K162106

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OOE 2017-02-03

LenSx Laser System

Applicant Alcon Laboratories, Inc.

K-Number K163551

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PQW 2017-02-03

SEEKER System

Applicant Baebies, Inc.

K-Number DEN150035

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