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 2019-05-14

ORTHOLOC 2 Lapidus with Rotation System

Applicant Wrightmedicaltechnologyinc

K-Number K190670

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FCX 2019-05-14

BAROnova Insufflation System, BAROnova Accessory Kit

Applicant Baronova, Inc.

K-Number K190985

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KWQ 2019-05-13

MVP Cervical Plate System

Applicant GS Medical Co., Ltd.

K-Number K190170

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LLZ 2019-05-13

SurgicalAR

Applicant Medivis, Inc.

K-Number K190764

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OWB 2019-05-13

ControlRad Trace Model 8

Applicant Controlrad, Inc.

K-Number K183109

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JKA 2019-05-13

PIVO

Applicant Velano Vascular

K-Number K190604

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PLO 2019-05-13

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K190219

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HBC 2019-05-12

MR8 Drill System, Midas Rex MR8 ClearView Tools

Applicant Medtronic Powered Surgical Solutions

K-Number K183515

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POS 2019-05-11

SPEAC System

Applicant Brain Sentinel, Inc.

K-Number K182180

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IRP 2019-05-10

Therm-X

Applicant Zenith Technical Innovations

K-Number K190854

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IYN 2019-05-10

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging, Inc.

K-Number K190995

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IYN 2019-05-10

6400 Ultrasound System (MyLabX6, MyLabX7)

Applicant Esaote, S.p.A.

K-Number K190989

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