Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

MQB 2016-03-18

Tuxedo Digital Dental Sensor

Applicant Led Dental, Inc.

K-Number K153710

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DXN 2016-03-18

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

Applicant Caretaker Medical, LLC

K-Number K151499

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LDJ 2016-03-18

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K153741

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DXX 2016-03-18

CorPath 200 System

Applicant Corindus, Inc.

K-Number K152999

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MNR 2016-03-18

AUDICOR CA300/CC100 Analyzer with SDB

Applicant Inovise Medical, Inc.

K-Number K151433

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OWI 2016-03-18

NILE Alternative Fixation Spinal System

Applicant K2m, Inc.

K-Number K160208

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GEX 2016-03-18

Quanta System Surgical Laser fibers

Applicant Quanta System Spa

K-Number K160513

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NGX 2016-03-18

Slim UP ULTRA

Applicant Aime Medical, Inc.

K-Number K151722

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DIO 2016-03-18

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K153646

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JWH 2016-03-18

Optetrak Advanced Patella

Applicant Exactech, Inc.

K-Number K160484

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KDI 2016-03-18

DBB-06 Hemodialysis Delivery System

Applicant NIKKISO CO., LTD.

K-Number K152938

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IYO 2016-03-18

FibroScan 530 Compact

Applicant Echosens

K-Number K160524

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