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 2017-03-16

Y3 Proximal Femoral Plate System

Applicant Pega Medical, Inc.

K-Number K163003

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PEK 2017-03-16

Kalitec Direct InSePtion MIS Fixation System

Applicant Kalitec Direct, LLC

K-Number K163471

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IYN 2017-03-16

6200 Ultrasound System and 6250 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K163082

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BZD 2017-03-15

SleepWeaver 3D Nasal Mask

Applicant Circadiance, LLC

K-Number K162905

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KXK 2017-03-15

LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source

Applicant Lv Liberty Vision Corp.

K-Number K163572

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MAX 2017-03-15

MOJAVE Expandable Interbody System

Applicant K2m

K-Number K163364

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HGX 2017-03-15

Spectra 9Plus

Applicant Uzinmedicare Company

K-Number K162415

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FMI 2017-03-14

Safety Blood Collection Set

Applicant Jiangsu Shenli Medical Production Co., Ltd.

K-Number K163093

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FFX 2017-03-14

Rapid Barostat Bag (RBB) Pump and Catheter

Applicant Mui Scientific

K-Number K160287

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DZE 2017-03-14

NobelZygoma 0°

Applicant Nobel Biocare AB

K-Number K161598

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JTN 2017-03-14

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

Applicant Hardy Diagnostics

K-Number K170127

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DXJ 2017-03-14

NIVR58-T kit

Applicant Barco N.V.

K-Number K161880

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