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

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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OLV 2017-12-19

Zmachine Synergy

Applicant Consolidated Research of Richmond, Inc. Dba General Sleep CO

K-Number K172986

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FEB 2017-12-19

Advantage Plus Pass-Thru

Applicant Medivators, Inc.

K-Number K172677

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NKB 2017-12-19

Reform® Midline Cortical Screw System

Applicant Precision Spine, Inc.

K-Number K173130

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IKN 2017-12-19

Natus VikingQuest

Applicant Natus Neurology Incorporated

K-Number K172743

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LNH 2017-12-19

MAGNETOM Amira

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173600

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MUH 2017-12-19

FS Ergo

Applicant Palodex Group OY

K-Number K173646

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FLL 2017-12-19

Digital thermometer(with disposable thermometer cover)

Applicant Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

K-Number K172861

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OAP 2017-12-19

SuperGrow 272, Ultimate 272

Applicant Super Grow Lasers

K-Number K172982

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FAJ 2017-12-19

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope

Applicant Solace Therapeutics, Inc.

K-Number K170862

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