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

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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IYE 2017-12-19

LumiCoil Platinum Fiducial Marker

Applicant Boston Scientific Corporation

K-Number K173251

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OCC 2017-12-19

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

Applicant Cepheid

K-Number K171552

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JWY 2017-12-19

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

Applicant Liofilchem s.r.l.

K-Number K173307

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