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

GXY 2017-05-08

Adhesive Electrodes

Applicant Reno Medical , Ltd.

K-Number K170744

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DQA 2017-05-08

Fingertip Pulse Oximeter

Applicant Xuzhou Yongkang Electronic Science Technology Co., Ltd.

K-Number K161938

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NHA 2017-05-08

CreoDent Solidex Customized Abutment

Applicant Creodent Prosthetics, Ltd.

K-Number K162734

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OVD 2017-05-08

Rampart One Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K163670

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LLZ 2017-05-08

Will3D

Applicant Hdx Will Corp.

K-Number K170180

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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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