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

DYB 2018-05-09

VSI Micro-Introducer Kit

Applicant Vascular Solutions, Inc.

K-Number K180913

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LZO 2018-05-09

Klassic HD® Hip System

Applicant Total Joint Orthopedics, Inc.

K-Number K180929

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MWP 2018-05-09

Faxitron VisionCT

Applicant Faxitron Bioptics, LLC

K-Number K173309

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PJJ 2018-05-09

STERIZONE VP4 Sterilizer

Applicant Tso3, Inc.

K-Number K172191

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JPA 2018-05-09

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

Applicant Sekisui Medical Co., Ltd.

K-Number K173202

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OMP 2018-05-09

Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad

Applicant Medela AG

K-Number K172145

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HCZ 2018-05-08

Fetzer Medical Gynecological Forceps

Applicant Fetzer Medical GmbH & Co. KG

K-Number K172661

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HIH 2018-05-08

MyoSure MANUAL Tissue Removal Device

Applicant Hologic, Inc.

K-Number K173901

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EMA 2018-05-08

Meron Plus QM

Applicant Voco GmbH

K-Number K180386

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JOH 2018-05-08

BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube

Applicant Smiths Medical Asd, Inc.

K-Number K173912

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FDS 2018-05-08

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Applicant Sumitomo Bakelite Co., Ltd.

K-Number K173004

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DYB 2018-05-08

Glidesheath Slender

Applicant Terumo Medical Corporation

K-Number K173831

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