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

LZO 2020-12-28

Quadra-P

Applicant Medacta International S.A.

K-Number K202730

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GWL 2020-12-27

8-CH Electroencephalography Amplifier

Applicant Hipposcreen Neurotech Corp.

K-Number K201747

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QNJ 2020-12-27

MBT Sepsityper

Applicant Bruker Daltonik GmbH

K-Number K193419

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POM 2020-12-25

ImPACT Version 4

Applicant Impact Applications, Inc.

K-Number K202485

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NFJ 2020-12-24

Image Quality Analyzer (IQA)

Applicant Visionquest Biomedical, Inc.

K-Number K200422

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MPB 2020-12-24

Acute Dual Lumen Hemodialysis Catheter

Applicant Health Line International Corporation

K-Number K200426

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GEX 2020-12-24

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K203544

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PEM 2020-12-23

Plasdent Disposable Barrier Sleeves and Barrier Film

Applicant Plasdent Corporation

K-Number K201604

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PTA 2020-12-23

Helix Genetic Health Risk App for late-onset Alzheimers disease

Applicant Helix Opco, LLC

K-Number K192073

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KWS 2020-12-23

AltiVate® Anatomic Pegged Glenoid with Markers

Applicant Encore Medical L.P.

K-Number K203026

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MQP 2020-12-23

F3D Corpectomy System

Applicant Corelink, LLC

K-Number K202637

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FLL 2020-12-23

DeRoyal Temperature Monitoring Probe

Applicant Deroyal Industries, Inc.

K-Number K200631

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