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

DXN 2020-12-30

Upper Arm Electronic Blood Pressure Monitor

Applicant Conmo Electronic Company Limited

K-Number K202372

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HWC 2020-12-30

Arthrex Low Profile Screws

Applicant Arthrex, Inc.

K-Number K203239

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GWQ 2020-12-30

NeuroAmp II, NeuroAmp II.5s

Applicant Corscience GmbH & Co. KG

K-Number K193159

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EZL 2020-12-30

Foley Balloon Catheter for Urology

Applicant Apollon Co., Ltd.

K-Number K201776

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FXX 2020-12-30

JianYu Surgical Mask

Applicant Jiangsu Jianyu Health Medical Co., Ltd.

K-Number K201754

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QJY 2020-12-30

Remunity Pump for Remodulin (treprostinil) Injection

Applicant Deka Research and Development

K-Number K202690

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HRS 2020-12-29

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K203511

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POL 2020-12-29

Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever

Applicant Stryker Neurovascular

K-Number K203219

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IYN 2020-12-29

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

Applicant Supersonic Imagine

K-Number K202455

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IYN 2020-12-29

Venue Fit

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K203137

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QAS 2020-12-29

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K203508

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JAA 2020-12-29

XR-MX/1000

Applicant Karl Storz Endoscopy America, Inc.

K-Number K200965

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