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

FMF 2018-05-10

Graftgun Universal Graft Delivery System

Applicant SurGenTec, LLC

K-Number K180937

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HSB 2018-05-10

OrthoPediatrics PediNail Intramedullary Platform

Applicant Orthopediatrics, Inc.

K-Number K172583

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KCT 2018-05-10

OsteoMed QuickFix Hybrid MMF Sterilization Tray

Applicant Osteomed, LLC

K-Number K173391

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KDI 2018-05-10

2008T BlueStar Hemodialysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K173972

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OVE 2018-05-10

Pro-Link® Ti Stand-Alone Cervical Spacer System

Applicant Life Spine, Inc.

K-Number K180642

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NGX 2018-05-09

Silk'n MODEL H5003 device

Applicant Home Skinovations , Ltd.

K-Number K180279

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IYE 2018-05-09

Halcyon

Applicant Varian Medical Systems, Inc.

K-Number K181032

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HWC 2018-05-09

Diamond Orthopedic Bone Fixation Screws and Pins

Applicant Diamond Orthopedic, LLC

K-Number K180932

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HRX 2018-05-09

ARTHRO-Pump PA304

Applicant W.O.M. World of Medicine GmbH

K-Number K173311

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MQV 2018-05-09

DSM Biomedical Calcium Phosphate Cement with Microspheres

Applicant Kensey Nash Corporation Dba Dsm Biomedical

K-Number K173572

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IYN 2018-05-09

Navi e/Navi s/Navi X Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K180461

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NRY 2018-05-09

EmboTrap ll Revascularization Device

Applicant Neuravi, Ltd.

K-Number K173452

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