Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

MQP 2017-05-16

VerteFIT Corpectomy Cage System

Applicant Ldr Spine USA, Inc.

K-Number K162133

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GEX 2017-05-16

SIROLaser Advance+

Applicant Dentsply Sirona

K-Number K170500

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ITX 2017-05-16

A-View

Applicant Stroke2prevent B.V.

K-Number K170338

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ITX 2017-05-16

iSR'obot Biopsy Kit

Applicant Biobot Surgical Pte., Ltd.

K-Number K163502

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LYZ 2017-05-16

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

Applicant Ever Global (Vietnam) Enterprise Corp

K-Number K170575

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MBI 2017-05-16

Arthrex Knotless SutureTak Anchor

Applicant Arthrex, Inc.

K-Number K171020

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PLF 2017-05-16

Tyber Medical Wedge System

Applicant Tyber Medical, LLC

K-Number K171327

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OWI 2017-05-16

TRANSLACE™ Spinal Tethering System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163181

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NKB 2017-05-16

Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory

Applicant Stryker Corporation

K-Number K170496

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JIT 2017-05-16

VITROS Immunodiagnostic Products Insulin Calibrators

Applicant Ortho Clinical Diagnostics

K-Number K171168

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KRA 2017-05-16

Direxion and Direxion HI-FLO Torqueable Microcatheters

Applicant Boston Scientific Corporation

K-Number K163701

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ONB 2017-05-16

TEVADAPTOR Closed Drug Reconstitution and Transfer System

Applicant Teva Medical Ltd., Migada Plant

K-Number K170680

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