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

MHX 2018-08-16

Multi-parameter Patient Monitor, models C30

Applicant Shenzhen Comen Medical Instruments Co.,Ltd

K-Number K173454

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EOX 2018-08-16

Cytosponge Cell Collection Device

Applicant Covidien, LLC

K-Number K181020

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OCC 2018-08-15

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

Applicant Cepheid

K-Number K181289

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OAP 2018-08-15

SuperGrow 272, Ultimate 272

Applicant Super Grow Lasers

K-Number K181308

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DYB 2018-08-15

RAIN Sheath Transradial

Applicant Cordis Corporation

K-Number K181592

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OWB 2018-08-15

Artis zee/zeego & Artis Q/Q.zen

Applicant Siemens Medical Solution USA, Inc.

K-Number K181407

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EBF 2018-08-15

BRILLIANT Crios

Applicant Coltene/Whaledent AG

K-Number K181500

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KNF 2018-08-15

Sonata Sonography-Guided Transcervical Fibroid Ablation System

Applicant Gynesonics, Inc.

K-Number K173703

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PMN 2018-08-15

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

Applicant Microbiologics, Inc.

K-Number K181711

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MAX 2018-08-15

Aries® Lumbar Interbodies

Applicant Osseus Fusion Systems, LLC

K-Number K181347

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LHN 2018-08-15

Mini Ridge Filter and auxiliary functions for PROBEAT-V

Applicant Hitachi Ltd. Healthcare Hitachi Works

K-Number K181676

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NHA 2018-08-15

InterActive SMARTBase Abutments

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K181359

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