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

NVE 2020-04-03

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

Applicant STERIS Corporation

K-Number K200577

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HET 2020-04-03

LAP-iX Suction Irrigation

Applicant Sejong Medical Co., Ltd.

K-Number K200638

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JOW 2020-04-03

Aria System

Applicant Inova Labs

K-Number K200564

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GCJ 2020-04-03

Visera Elite II Video System Center, Visera Elite II Endoeye 3D

Applicant Olympus Medical Systems Corp.

K-Number K193026

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PSQ 2020-04-03

ADAPT Tissue

Applicant Admedus Regen Pty, Ltd.

K-Number K200566

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GEX 2020-04-03

Diode Laser Hair Removal Machine

Applicant Beijing Lead Beauty S & T Co., Ltd.

K-Number K192735

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OWB 2020-04-03

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

Applicant Livermoretech, Inc.

K-Number K200022

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PSZ 2020-04-03

Osom Ultra Plus Flu A&B Test Kit

Applicant SEKISUI Diagnostics, LLC

K-Number K192719

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DZE 2020-04-03

Faico Dental Implant System

Applicant Faico Medical, LLC

K-Number K192015

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MAX 2020-04-02

SIRION Lateral Lumbar Interbody System

Applicant Astura Medical, LLC

K-Number K192006

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JOJ 2020-04-02

QwikCheck Chemical Indicators

Applicant Serim Research Corporation

K-Number K192445

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GEI 2020-04-02

ARC 400

Applicant Bowa-Electronics GmbH & Co. KG

K-Number K193591

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