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

HRS 2018-01-16

Activ Ankle

Applicant Newclip Technics

K-Number K173641

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NHA 2018-01-15

Elos Accurate Customized Abutment, Elos Prosthetic Screw

Applicant Elos Medtech Pinol A/S

K-Number K171799

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NHN 2018-01-13

MR4 Laser

Applicant Multi Radiance Medical

K-Number K171354

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HIS 2018-01-12

One Touch Condom with Benzocaine

Applicant Thai Nippon Rubber Industry Public Company Limited.

K-Number K171213

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PSU 2018-01-12

ipsogen JAK2 RGQ PCR Kit

Applicant Qiagen, Inc.

K-Number K172287

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IZL 2018-01-12

Optima XR240amx, AutoGrid

Applicant Ge Medical Systems, LLC

K-Number K173602

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NUC 2018-01-12

K-Y Silicone

Applicant Reckitt Benckiser, LLC

K-Number K173504

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BSZ 2018-01-12

A5 Anesthesia System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K171311

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IPL 2018-01-12

Action Trackstander models TR1816, TR1820, TR2016, and TR2020

Applicant Action Manufacturing, Inc.

K-Number K163451

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KPS 2018-01-12

ImagenUniversal

Applicant Cardiovascular Imaging Technologies

K-Number K173547

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DCN 2018-01-12

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

Applicant Meso Scale Diagnostics, LLC

K-Number K171498

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KTT 2018-01-12

ARBOR External Fixation System

Applicant Globus Medical, Inc.

K-Number K172438

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