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

MQC 2020-11-25

Night Guard

Applicant 3D Diagnostix, Inc.

K-Number K202465

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QNF 2020-11-24

Monet Curing Laser

Applicant CAO Group, Inc.

K-Number K201904

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QMW 2020-11-24

CADScor System

Applicant Acarix A/S

K-Number DEN190047

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KWQ 2020-11-24

Anterior Cervical Plate System

Applicant Nutech Spine and Biologics

K-Number K202972

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GEH 2020-11-24

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant Pentax of America, Inc.

K-Number K203024

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FXX 2020-11-24

Medical surgical mask

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K201622

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KCT 2020-11-24

NUVO Implant System NUVO Instrument Kit Cases

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K202515

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FOZ 2020-11-24

ACENT Central Venous Catheter

Applicant Global Medikit Limited

K-Number K193158

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GAS 2020-11-24

RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene

Applicant Lsi Solutions, Inc.

K-Number K203120

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GEI 2020-11-24

RF Surgical Generator

Applicant Fulwell, LLC

K-Number K200931

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EMA 2020-11-24

G-CEM ONE

Applicant GC America, Inc.

K-Number K200798

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HRS 2020-11-24

PolyLock Plating System

Applicant Fusion Orthopedics, LLC

K-Number K202959

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