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

JDR 2018-07-24

DePuy Synthes Static Staples

Applicant Synthes (USA) Products, LLC

K-Number K180544

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JCX 2018-07-24

TWBM Pump

Applicant Taiwan Biomaterial Co., Ltd.

K-Number K180115

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DSH 2018-07-24

Portable ECG Monitor (ECG3)

Applicant Andon Health Co, Ltd.

K-Number K172862

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FRC 2018-07-24

CELERITY 20 Steam Biological Indicator

Applicant STERIS Corporation

K-Number K181686

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PBX 2018-07-24

RF-Relief

Applicant El Global Trade, Ltd.

K-Number K181095

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EFB 2018-07-24

Dental High-speed Handpiece and Accessories

Applicant Microp Technology (Taiwan), Inc.

K-Number K173943

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GWN 2018-07-24

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

Applicant Neuro Kinetics, Inc.

K-Number K181025

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PQC 2018-07-24

FIREFLY® Pedicle Screw Navigation Guide

Applicant Mighty Oak Medical, Inc.

K-Number K181399

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DZE 2018-07-24

S-mini active Fixture

Applicant Neobiotech Co., Ltd.

K-Number K181178

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NKB 2018-07-24

Altus Spine Pedicle Screw System

Applicant Altus Partners, LLC

K-Number K181339

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PPW 2018-07-24

CipherOx CRI M1

Applicant Flashback Technologies, Inc.

K-Number K173929

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FMI 2018-07-24

Autokeeper

Applicant Medexel Co.,Ltd

K-Number K172095

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