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

DXN 2018-03-27

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K170605

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KWQ 2018-03-27

Zavation Buttress Plate System

Applicant Zavation Medical Products, LLC

K-Number K180537

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MUJ 2018-03-27

Prelude

Applicant Medcom GmbH

K-Number K180308

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DQA 2018-03-27

Pulse Oximeter

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K-Number K171241

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PML 2018-03-27

FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

Applicant Globus Medical, Inc.

K-Number K172269

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MRC 2018-03-27

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution

Applicant Bausch and Lomb, Incorporated

K-Number K180319

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LPH 2018-03-27

Mpact® 3D Metal™ Implants and Augments 3D Metal™

Applicant Medacta International S.A.

K-Number K171966

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NUJ 2018-03-27

NES Reprocessed RF Stylet (RFS)

Applicant Northeast Scientific, Inc. (Nes)

K-Number K173214

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ERL 2018-03-27

OCM-G1 Attachment

Applicant The Anspach Effort, Inc.

K-Number K180063

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OOE 2018-03-27

LenSx Laser System

Applicant Alcon Laboratories, Inc.

K-Number K173660

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LFL 2018-03-26

Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide

Applicant Covidien, LLC

K-Number K180149

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LRK 2018-03-26

REST EAZY Appliance

Applicant Insert Molding Solutions, Inc.

K-Number K172760

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