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

ODP 2017-12-20

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

Applicant Globus Medical, Inc.

K-Number K173115

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HSB 2017-12-20

Apex Tibial Nailing System

Applicant Orthoxel

K-Number K170972

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DYB 2017-12-20

Sentrant Introducer Sheath with Hydrophilic Coating

Applicant Medtronic Vascular, Inc.

K-Number K171866

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DQY 2017-12-20

speX Support Catheter

Applicant Reflow Medical, Inc.

K-Number K173662

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HRS 2017-12-20

Breakaway Screw System

Applicant Paragon 28

K-Number K172886

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DYB 2017-12-20

Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design

Applicant Cook Incorporated

K-Number K171275

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KPS 2017-12-20

Biograph mCT Family of PET/CT Systems

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173578

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DYB 2017-12-20

Peel-Away Introducer Set

Applicant Cook Incorporated

K-Number K173685

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ORC 2017-12-20

Operio

Applicant Toul Meditech AB

K-Number K173349

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MAX 2017-12-20

ProLift® Expandable System

Applicant Life Spine, Inc.

K-Number K173182

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PWJ 2017-12-20

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

Applicant Boston Scientific Corporation

K-Number K172565

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NFO 2017-12-20

Pobling MIITY 2

Applicant Habalan Med & Beauty Co.,Ltd

K-Number K163550

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