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

GWG 2017-08-14

Artemis Neuro Evacuation Device

Applicant Penumbra, Inc.

K-Number K171332

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NHA 2017-08-14

ATLANTIS suprastructures

Applicant Dentsply Sirona

K-Number K163398

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HRS 2017-08-14

ARIX Foot System (2.3/2.8)

Applicant Jeil Medical Corporation

K-Number K170780

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JOJ 2017-08-14

3M Comply Hydrogen Peroxide Chemical Indicator 1248

Applicant 3M Company

K-Number K170321

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HWC 2017-08-11

TalarLift STS

Applicant Fusion Orthopedics, LLC

K-Number K170624

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KWQ 2017-08-11

NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K163625

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QSZ 2017-08-11

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)

Applicant Polynovo Biomaterials Pty, Ltd.

K-Number K172140

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CBK 2017-08-11

Breathe Technologies Life2000 Ventilation System

Applicant Breathe Technologies

K-Number K170037

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GKZ 2017-08-11

ADVIA 2120i, ADVIA 2120

Applicant Siemens Healthcare Diagnostics

K-Number K162977

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NUH 2017-08-11

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

Applicant Easywell Biomedicals, Inc.

K-Number K163166

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OHT 2017-08-11

Silk'n Infinity

Applicant Home Skinovations , Ltd.

K-Number K171433

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NTI 2017-08-11

xTAG CYP2D6 Kit v3

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K170492

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