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

KWQ 2018-02-26

TRYPTIK2 C-Plate Anterior Cervical Plate System

Applicant Spineart

K-Number K171797

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ODP 2018-02-26

Neurostructures Cavetto® Cervical Cage System

Applicant Neurostructures, Inc.

K-Number K172320

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KIF 2018-02-26

ENDOSEAL MTA

Applicant Maruchi

K-Number K170175

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EBF 2018-02-24

Trilor Disks, Blocks and Arches

Applicant Bioloren S.R.L.

K-Number K173643

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JDR 2018-02-23

Orbitum Bone Staple Implant, X and VI

Applicant Orthovestments, LLC

K-Number K173693

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KDI 2018-02-23

Prismaflex System 8.10

Applicant Baxter Healthcare Corporation

K-Number K171671

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NFJ 2018-02-23

Ophthalmic Software Platform RX

Applicant Canon Inc. -Medical Equipment Group

K-Number K173689

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KWH 2018-02-23

RTS Lesser MTP Implant System

Applicant In2bones USA, LLC

K-Number K173491

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JEY 2018-02-23

KLS Martin L1 MMF System

Applicant KLS Martin L.P.

K-Number K173320

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DKZ 2018-02-23

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)

Applicant Alfa Scientific Designs, Inc.

K-Number K173303

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GEX 2018-02-23

InMode VLaze

Applicant Inmode MD , Ltd.

K-Number K173677

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QSY 2018-02-23

Axiostat Chitosan Hemostatic Dressing

Applicant Advamedica, Inc.

K-Number K172324

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