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

EJI 2017-11-16

LeEject 2 Dental Syringe and Needle System

Applicant Advanced Technology and Capital, Inc.

K-Number K171254

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PLC 2017-11-16

Acrylic Herbst Appliance with Micro-Recorder

Applicant Gergen'S Orthodontic Lab

K-Number K170606

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JWH 2017-11-16

JOURNEY II XR Knee Instruments

Applicant Smith & Nephew, Inc.

K-Number K173331

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OXO 2017-11-16

OEC Elite

Applicant Ge Oec Medical Systems, Inc.

K-Number K172550

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MSD 2017-11-16

Symetrex Long Term Hemodialysis Catheter

Applicant Medcomp (Dba Medical Components, Inc.)

K-Number K171618

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PZS 2017-11-16

MC3 QuickFlow Dual Lumen Catheter

Applicant Mc3 Incorporated

K-Number K171610

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GEI 2017-11-16

Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider

Applicant Stryker Sustainability Solutions

K-Number K172856

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MRC 2017-11-16

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Applicant Menicon Co, Ltd.

K-Number K173136

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IZL 2017-11-16

MobileDiagnost M50

Applicant Philips India Limited

K-Number K173187

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DXH 2017-11-16

Kardia Band System

Applicant AliveCor, Inc.

K-Number K171816

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GEI 2017-11-16

Bipolar applicator CELON ProCurve V

Applicant Olympus Winter & Ibe GmbH

K-Number K172535

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OBJ 2017-11-16

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

Applicant Boston Scientific Corporation

K-Number K173284

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