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

IYN 2016-01-13

S50 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K152854

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MUI 2016-01-13

Sonishield 100 Antimicrobial Ultrasound Gel

Applicant Quotient Medical

K-Number K151070

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NRY 2016-01-13

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

Applicant Penumbra, Inc.

K-Number K152541

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PDQ 2016-01-13

NuVasiveNVM5 System

Applicant Nu Vasive, Incorporated

K-Number K152942

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JXI 2016-01-13

Nerve Capping Device

Applicant Polyganics Innovations BV

K-Number K152684

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NUH 2016-01-13

LL TENS 160A, LL TENS 160B

Applicant Fuji Dynamics , Ltd.

K-Number K152374

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JDQ 2016-01-13

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

Applicant Frontier Medical Devices, Inc.

K-Number K153242

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KTT 2016-01-13

Reprocessed Stryker External Fixation Devices

Applicant Stryker Sustainability Solutions

K-Number K153415

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KTT 2016-01-13

SALVATION(R) External Fixation System

Applicant Wrightmedicaltechnologyinc

K-Number K153635

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NTB 2016-01-13

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

Applicant Acoustic Medsystems, Inc.

K-Number K150019

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LLZ 2016-01-12

ImplantMax Software

Applicant Saturn Imaging, Inc.

K-Number K151152

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KCT 2016-01-12

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K151450

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