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

GEX 2018-07-05

400um Perforator and Accessory Vein Ablation Kit

Applicant AngioDynamics, Inc.

K-Number K181044

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LZA 2018-07-05

Nitrile Patient Examination Powder Free Glove, Textured, Black

Applicant Multisafe Sdn. Bhd.

K-Number K161085

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NAY 2018-07-05

SureForm 60 and SureForm 60 Reloads

Applicant Intuitive Surgical

K-Number K173721

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DPS 2018-07-05

CheckMyHeart Plus

Applicant Dailycare Biomedical, Inc.

K-Number K172778

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NIE 2018-07-05

12F Tri-Flow Triple Lumen Catheter

Applicant Medical Components, Inc. (dba MedComp)

K-Number K181175

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NRY 2018-07-04

Riptide Aspiration System React 68 Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K180705

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DQY 2018-07-04

React 68 Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K180715

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KTI 2018-07-03

PeriView FLEX

Applicant Olympus Surgical Technologies America

K-Number K181193

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MQB 2018-07-03

XRpad2 4343 HWC-M Flat Panel Detector

Applicant Varex Imaging Corporation

K-Number K181526

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JWY 2018-07-03

ETEST Telavancin (TLA) (0.002-32 ug/mL)

Applicant Biomerieux S.A.

K-Number K180936

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FGB 2018-07-03

Ureterorenoscope System

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K180367

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EBF 2018-07-03

Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit

Applicant Figaro Crowns, Inc.

K-Number K172952

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