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

GYC 2019-03-12

AirRay Subdural Cortical Electrodes

Applicant Cortec GmbH

K-Number K183437

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HRS 2019-03-11

EVOS Small Fragment Upper Extremity Plates Line Additions

Applicant Smith & Nephew, Inc.

K-Number K190253

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DZE 2019-03-11

BoneTrust Implant System

Applicant Medical Instinct Deutschland GmbH

K-Number K182313

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DQK 2019-03-11

KardiaAI

Applicant AliveCor, Inc.

K-Number K181823

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GEI 2019-03-11

EasyInstruments

Applicant Agency For Medical Innovations GmbH

K-Number K182013

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LZA 2019-03-11

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

Applicant Sri Trang Gloves (Thailand) Co., Ltd.

K-Number K182241

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MAI 2019-03-11

Rotium Bioresorbable Wick

Applicant Nanofiber Solutions, LLC

K-Number K183236

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DZJ 2019-03-11

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K182789

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DQX 2019-03-11

Inno-Pathwire

Applicant Suzhou Innomed Medical Device Co., Ltd.

K-Number K182553

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GXI 2019-03-08

Nitinol Thermocouple (TCN) Electrode

Applicant Boston Scientific Corporation

K-Number K183177

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ITI 2019-03-08

Bariatric Power Positioning System (BPPS)

Applicant Motion Concepts

K-Number K182995

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KWS 2019-03-08

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

Applicant Arthrex, Inc.

K-Number K182799

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