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

OOE 2020-09-01

VICTUS Femtosecond Laser Platform

Applicant Technolas Perfect Vision GmbH

K-Number K200724

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QBR 2020-08-31

TrueTear Intranasal Tear Neurostimulator

Applicant Allergan

K-Number K193589

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NRY 2020-08-31

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)

Applicant Penumbra, Inc.

K-Number K202251

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PPT 2020-08-31

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K201052

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NDN 2020-08-31

CONFIDENCE Spinal Cement System

Applicant Depuy Spine, Inc.

K-Number K201831

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LON 2020-08-30

LabPro Data Management System

Applicant Beckman Coulter, Inc.

K-Number K201405

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MUD 2020-08-29

Masimo O3 Regional Oximeter System

Applicant Masimo Corporation

K-Number K201432

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KNW 2020-08-28

Temno Elite Biopsy System

Applicant Merit Medical Systems, Inc.

K-Number K201166

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QSY 2020-08-28

Hemostatic Xerogel Sponge

Applicant Solaplus Biotech Co., Ltd.

K-Number K192671

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DRN 2020-08-28

External Counterpulsation System, Soulaire

Applicant Vamed Medical Instrument Co., Ltd.

K-Number K202108

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KDI 2020-08-28

DIMI RRT System

Applicant Dialco Medical, Inc.

K-Number K193005

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MHX 2020-08-28

Infinity M300

Applicant Draeger Medical Systems, Inc.

K-Number K200859

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