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 2017-09-21

ZS3 Ultrasound System, z.one pro Ultrasound System

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

K-Number K171891

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LPH 2017-09-21

iNSitu Total Hip System

Applicant Theken Companies, LLC

K-Number K172501

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FRO 2017-09-21

Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle

Applicant Anexa Biomedical, Inc.

K-Number K172486

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HRS 2017-09-21

ARIX Wrist System

Applicant Jeil Medical Corporation

K-Number K170705

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JHX 2017-09-21

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

Applicant Radiometer Medical Aps

K-Number K163462

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NHA 2017-09-21

Eztetic BellaTek Encode Healing Abutments

Applicant Biomet 3i

K-Number K170013

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NAY 2017-09-21

da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes

Applicant Intuitive Surgical, Inc.

K-Number K170641

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JMT 2017-09-21

Scanostics UTI Check Application Test System

Applicant Teco Diagnostics

K-Number K170118

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OWB 2017-09-21

EndoNaut

Applicant Therenva Sas

K-Number K171829

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OMB 2017-09-21

Persyst Mobile App

Applicant Persyst Development Corporation

K-Number K171184

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BTT 2017-09-21

Salter Labs Bubble Humidifier

Applicant Salter Labs

K-Number K161719

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HRS 2017-09-21

DARCO Locking Bone Plate System

Applicant Wrightmedicaltechnologyinc

K-Number K171852

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