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

EBZ 2017-11-27

LED Curing Light

Applicant Monitex Industrial Co., Ltd.

K-Number K161855

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NHA 2017-11-27

Straumann Screw Retained Abutments

Applicant Straumann USA, LLC (On Behalf of Institut Straumann Ag)

K-Number K171757

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PMN 2017-11-24

FilmArray RP2/RP2plus Control Panel

Applicant Maine Molecular Quality Controls, Inc.

K-Number K173171

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KCT 2017-11-24

SALUS - Hygiene Instrument Reprocessing Container

Applicant Scican , Ltd.

K-Number K172292

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PZF 2017-11-24

FilmArray Respiratory Panel 2 plus (RP2plus)

Applicant Biofire Diagnostics, LLC

K-Number DEN170017

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GZL 2017-11-24

DIXI Medical Microdeep Depth Electrode

Applicant Dixi Medical

K-Number K170959

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OLO 2017-11-24

ExactechGPS Total Shoulder Application

Applicant Blue Ortho

K-Number K173372

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OXO 2017-11-24

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant

Applicant Skanray Technologies Private Limited

K-Number K170946

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LRK 2017-11-24

True Function Adjustable Herbst Appliances

Applicant True Function Laboratory, Inc.

K-Number K170578

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LZA 2017-11-24

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE

Applicant Shen Wei USA, Inc.

K-Number K172678

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MQV 2017-11-24

NuVasive AttraX Scaffold

Applicant Nu Vasive, Incorporated

K-Number K172497

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KPR 2017-11-22

GC85A

Applicant Samsung Electronics Co., Ltd.

K-Number K172229

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