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

PDJ 2018-07-12

SEKURE HbA1c Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K-Number K173206

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NBW 2018-07-12

ActiveCare TD-4121 Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K173511

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KWT 2018-07-12

Catalyst CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K181287

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MOV 2018-07-12

Modified Novy Cornual Cannulation Set

Applicant Cook Incorporated

K-Number K180552

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PZI 2018-07-12

StatStrip Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K181043

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MMI 2018-07-12

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K171274

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IYN 2018-07-11

Transcranial Doppler Ultrasound System

Applicant Shenzhen Delica Medical Equipment Co., Ltd.

K-Number K173801

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FMI 2018-07-11

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G

Applicant Owen Mumford, Ltd.

K-Number K173881

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DSI 2018-07-11

Medicalgorithmics Unified Cardiac Rehabilitation System

Applicant Medicalgorithmics S.A.

K-Number K173969

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MOS 2018-07-11

16ch Foot/ Ankle SPEEDER

Applicant Quality Electrodynamics, LLC

K-Number K181697

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HWC 2018-07-11

SALVATION Midfoot Nail

Applicant Wrightmedicaltechnologyinc

K-Number K180024

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OWB 2018-07-11

Intelli-C

Applicant Nrt X-Ray A/S

K-Number K173631

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