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

QFO 2019-07-17

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K191578

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LRK 2019-07-17

Silent Nite sl

Applicant Prismatik Dentalcraft, Inc.

K-Number K183270

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PKT 2019-07-17

Powersculp laser lipolysis system

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K191068

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HRS 2019-07-17

ORTHOLOC SPS Shoulder Plating System

Applicant Tornier, Inc.

K-Number K191711

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NQZ 2019-07-17

Fungitell STAT

Applicant Associates of Cape Cod, Inc.

K-Number K191167

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HRX 2019-07-17

Pegasus System

Applicant A.M. Surgical, Inc.

K-Number K191345

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MBI 2019-07-17

Xtreme-Loop

Applicant Xiros, Ltd.

K-Number K191053

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MQC 2019-07-17

The POD

Applicant Advanced Facialdontics, LLC

K-Number K182820

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DQO 2019-07-16

Impress Angiographic Catheter

Applicant Merit Medical Systems, Inc.

K-Number K191608

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PDQ 2019-07-16

ALARA Neuro Access Kit

Applicant SurGenTec, LLC

K-Number K190163

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NBY 2019-07-16

Biotex

Applicant Purgo Biologics, Inc.

K-Number K180992

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FLL 2019-07-16

Microlife Digital Infrared Ear Thermometer

Applicant Microlife Intellectual Property GmbH

K-Number K183663

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