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

KWS 2017-06-19

Materialise Glenoid Positioning System

Applicant Materialise NV

K-Number K170893

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NGX 2017-06-19

Compex Wireless USA

Applicant Djo, LLC

K-Number K170903

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MAX 2017-06-19

Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System

Applicant Vertera, Inc.

K-Number K163506

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GEX 2017-06-19

DEKA MOTUS AX

Applicant El.En Electronic Engineering Spa

K-Number K162886

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LFD 2017-06-19

Hydris Oral Rinse

Applicant Biopharm Consult, LLC

K-Number K163029

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KNW 2017-06-19

Möller Medical Biopsy Needles and Systems

Applicant Moller Medical GmbH

K-Number K162588

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NDC 2017-06-19

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K-Number K170669

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MCW 2017-06-16

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

Applicant Medtronic Vascular, Inc.

K-Number K170191

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OAS 2017-06-16

Green16/Green18 (Model: PHT-65LHS)

Applicant VATECH Co., Ltd.

K-Number K170066

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OWB 2017-06-16

Infinix INFX-8000V, V6.40

Applicant Toshiba Medical Systems Coroporation

K-Number K170909

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GEX 2017-06-16

Diode Laser Hair Removal System

Applicant Shandong Huamei Technology Co., Ltd.

K-Number K162659

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HRS 2017-06-16

Alians Fragment Specific

Applicant Newclip Technics

K-Number K170843

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