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

FIZ 2020-09-02

SmartHDM-510 System

Applicant Mesa Laboratories, Inc.

K-Number K201765

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IYT 2020-09-01

Patient Administration Set

Applicant Cyclomedica Australia Pty, Ltd.

K-Number K200916

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FEB 2020-09-01

Endoscope Reprocessor OER-Elite

Applicant Olympus Medical Systems Corp.

K-Number K201920

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FET 2020-09-01

Image1 S CCU, Image1 S 4U Camera Head

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K201135

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IYN 2020-09-01

Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K202160

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PKL 2020-09-01

Resolution 360 ULTRA Clip

Applicant Boston Scientific Corporation

K-Number K193424

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OAP 2020-09-01

CAPOGEN Laser Cap

Applicant Nature, Inc.redible, Inc.

K-Number K201854

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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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