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

NEY 2017-05-05

Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

Applicant AngioDynamics, Inc.

K-Number K162449

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DHB 2017-05-05

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE

Applicant Phadia AB

K-Number K163370

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NKB 2017-05-05

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System

Applicant Orthofix, Inc.

K-Number K171082

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ILY 2017-05-05

Softcure 96

Applicant Wellray Medical Laser, Inc.

K-Number K170068

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EZL 2017-05-05

Rusch Silicone Foley Catheter

Applicant Teleflexmedical, Inc.

K-Number K161770

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ITI 2017-05-05

A08 Power wheelchair

Applicant Kunshan Aoshida Electric Technology Co., Ltd.

K-Number K163204

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MUD 2017-05-05

Kent Camera

Applicant Kent Imaging, Inc.

K-Number K163070

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OUR 2017-05-05

SICAGE System

Applicant Sicage, LLC

K-Number K170475

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PBJ 2017-05-05

Internal Distraction - Sterile

Applicant KLS Martin L.P.

K-Number K163315

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FGB 2017-05-05

Medical Video Endoscope System

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K171076

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HRS 2017-05-05

Colink Plating System

Applicant In2bones USA, LLC

K-Number K163293

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MNR 2017-05-05

MATRx plus

Applicant Zephyr Sleep Technologies

K-Number K163665

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