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

KJJ 2020-07-06

RC-Prime Root Canal Preparation Cream

Applicant Pac-Dent, Inc.

K-Number K200330

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FDS 2020-07-06

Fujifilm Ultrasonic Processor

Applicant Fujifilm Corporation

K-Number K200850

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NHA 2020-07-06

MIS Ti-base Abutment

Applicant Dentsply Sirona

K-Number K191152

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DQA 2020-07-03

Oxxiom

Applicant True Wearables, Inc.

K-Number K200537

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MXD 2020-07-03

LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit

Applicant Medtronic, Inc.

K-Number K200795

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JOW 2020-07-02

VenaOne

Applicant Vena Group, LLC

K-Number K200285

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DSA 2020-07-02

AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

Applicant Atrility Medical, LLC

K-Number K200674

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PMS 2020-07-02

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

Applicant Ivwatch, LLC

K-Number K192385

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FTC 2020-07-02

Psoria-Shield AURORA

Applicant Psoria-Shield

K-Number K192411

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IZQ 2020-07-02

ulrichINJECT CT Motion

Applicant Ulrich GmbH & Co. KG

K-Number K192872

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FRC 2020-07-02

3M Attest Steam Chemical Integrator Test Pack

Applicant 3M Company

K-Number K200766

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IYN 2020-07-02

Terason uSmart 3200T Plus Ultrasound System

Applicant Teratech Corporation

K-Number K201633

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