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

DRN 2020-08-05

Enhanced External Counter Pulsation Device Plus Omay-A

Applicant Omay(Guangzhou)Med Technologies Co., Ltd.

K-Number K191955

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HWC 2020-08-04

Vector Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K201850

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KPS 2020-08-04

HYPER DLR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K193210

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GKR 2020-08-04

HemoCue Hb 301 System

Applicant Hemocue AB

K-Number K201217

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LZO 2020-08-04

Corin Optimized Positioning System (OPS) Femoral

Applicant Corin USA

K-Number K193545

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MAX 2020-08-04

Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer

Applicant Life Spine, Inc.

K-Number K201500

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PEK 2020-08-04

CoFix System

Applicant Paradigm Spine GmbH

K-Number K201704

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QDA 2020-08-04

ECG Monitor App

Applicant Samsung Electronics Co., Ltd.

K-Number K201168

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MQV 2020-08-04

CureOs TCP

Applicant Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic

K-Number K191670

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LZA 2020-08-04

Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

Applicant Medline Industries, Inc.

K-Number K193666

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IPF 2020-08-04

ETD Family of Electrotherapy Devices

Applicant Therasigma, LLC

K-Number K201958

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GEI 2020-08-03

Electrodes Handpieces for Mygen V-1000 RF System

Applicant RF Medical Co., Ltd.

K-Number K193355

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