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

NLH 2019-10-30

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K191170

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KRD 2019-10-30

Okami Medical LOBO Vascular Occlusion System

Applicant Okami Medical

K-Number K192083

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OQY 2019-10-30

Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)

Applicant Ujenzi Charitable Trust

K-Number K191264

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PJB 2019-10-30

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

Applicant Stereotaxis, Inc.

K-Number K192775

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MGZ 2019-10-30

EZE SIT Valvulotome

Applicant Lemaitre Vascular

K-Number K190267

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HRS 2019-10-30

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K192504

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HWC 2019-10-30

Arthrex Low Profile Screws

Applicant Arthrex, Inc.

K-Number K190921

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MAX 2019-10-30

IB3D ALIF

Applicant Medicrea International SA

K-Number K191134

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DHA 2019-10-30

Atellica IM Total hCG (ThCG)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K192790

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LCP 2019-10-29

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

Applicant Ixensor Co, Ltd.

K-Number K192369

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MNR 2019-10-29

MATRx Plus

Applicant Zephyr Sleep Technologies

K-Number K191925

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MBB 2019-10-29

G21 SpaceFlex Hip

Applicant G21, S.R.L.

K-Number K192041

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