Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2016-04-04

S45 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K160283

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MSD 2016-04-04

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

Applicant Merit Medical Systems, Inc.

K-Number K151967

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NBW 2016-04-01

TRUE METRIX GO Self Monitoring Blood Glucose System

Applicant Trividia Health, Inc.

K-Number K143548

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DQK 2016-04-01

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Applicant Spacelabs Healthcare, Ltd.

K-Number K152881

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IZH 2016-04-01

Affirm Prone Biopsy System

Applicant Hologic, Inc.

K-Number K153486

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MNI 2016-04-01

Premier

Applicant Shandong Weigao Orthopaedic Device Co., Ltd.

K-Number K160320

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LZA 2016-04-01

Powder Free Blue Nitrile Examination Glove

Applicant Vietglove Corporation

K-Number K153562

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IYN 2016-04-01

X5 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K160258

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MWP 2016-04-01

BioVision Plus

Applicant Faxitron Bioptics, LLC

K-Number K153583

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JAK 2016-04-01

Aquilion Lightning, TSX-035A/4 and /5, V7.0

Applicant Toshibamedical Systems Corporation

K-Number K153263

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PCH 2016-04-01

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160459

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EBF 2016-04-01

Pulpdent Solo Flowable Composite with MCP

Applicant Pulpdent Corporation

K-Number K153249

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