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

NDN 2017-02-27

Kyphon Xpede Bone Cement

Applicant Medtronic, Inc.

K-Number K163032

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DYB 2017-02-27

Flextra Steerable Introducer

Applicant Rhythm Xience, Inc. (Rxi)

K-Number K170373

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NKB 2017-02-24

Revolution™ Spinal Fixation System

Applicant Intelligent Implant Systems, LLC

K-Number K163056

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MQV 2017-02-24

MagnetOs

Applicant Xpand Biotechnology BV

K-Number K161859

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CCK 2017-02-24

TG-970P CO2 Sensor Kit

Applicant Nihon Kohden Corporation

K-Number K161860

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EOB 2017-02-24

3NT endoscopy system

Applicant 3nt Medical , Ltd.

K-Number K162916

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EBF 2017-02-24

Renamel NANO +plus

Applicant Cosmedent, Inc.

K-Number K163480

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FOZ 2017-02-24

Arrow Endurance Extended Dwell Peripheral Catheter System

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K163513

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MUU 2017-02-24

The Red Head Collection Device, The Jordy Connection System

Applicant Miami Fat Supply

K-Number K161372

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OAP 2017-02-24

IllumiFlow Laser Cap

Applicant Eglobal, LLC

K-Number K162071

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QEY 2017-02-24

EkoSonic Endovascular System with Control Unit 4.0

Applicant Btg International, Inc.

K-Number K162771

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NFO 2017-02-24

ZIIP Device

Applicant Ziip,Llc

K-Number K161484

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