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

EBF 2018-06-07

Tetric CAD

Applicant Ivoclar Vivadent, AG

K-Number K173573

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PMC 2018-06-07

Paxman Scalp Cooler

Applicant Paxman Coolers Limited

K-Number K173032

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HKY 2018-06-07

AT 030

Applicant Carl Zeiss Meditec, AG

K-Number K180839

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PLP 2018-06-07

FOCAL ONE

Applicant Edap Technomed, Inc.

K-Number K172721

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LLZ 2018-06-07

QLAB Advanced Quantification Software

Applicant Philips Ultrasound, Inc.

K-Number K181264

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ONN 2018-06-07

VERASENSE for Zimmer Biomet Persona

Applicant Orthosensor, Inc.

K-Number K180459

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FTL 2018-06-07

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

Applicant Medtronic, Inc.

K-Number K180122

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MQG 2018-06-07

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K-Number K180188

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NUH 2018-06-07

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K180956

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LNH 2018-06-06

uMR 560

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K180926

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LYY 2018-06-06

POWDER FREE LATEX EXAMINATION GLOVE

Applicant Professional Latex Sdn Bhd

K-Number K173053

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DJG 2018-06-06

ARK Fentanyl Assay

Applicant Ark Diagnostics, Inc.

K-Number K180427

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