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

DZE 2018-08-17

BTI Dental Implant System UnicCa

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K173257

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OAS 2018-08-17

PreXion 3D Excelsior

Applicant Prexion Corporation

K-Number K181983

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DQA 2018-08-17

Optical Topography System ETG-4100

Applicant Hitachi Healthcare Americas

K-Number K172492

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NRY 2018-08-17

Penumbra System Reperfusion Catheter JET 7

Applicant Penumbra, Inc.

K-Number K173761

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DRY 2018-08-17

Quantum Workstation 12.1

Applicant Spectrum Medical , Ltd.

K-Number K181923

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DZE 2018-08-17

OsteoReady Dental Implant System

Applicant Osteoready, LLC

K-Number K173575

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OWB 2018-08-17

Cios Select

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181767

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IYN 2018-08-17

CBit Series Digital Color Doppler Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K180974

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OXC 2018-08-17

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

Applicant W. L. Gore & Associates, Inc.

K-Number K181940

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GZJ 2018-08-17

BioWaveGO

Applicant Biowave Corporation

K-Number K180943

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QCI 2018-08-17

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

Applicant Brainways , Ltd.

K-Number DEN170078

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NBW 2018-08-17

Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus

Applicant Bionime Corporation

K-Number K173638

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