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

GXY 2021-02-09

MR Conditional Sticky Pad Electrode

Applicant Rhythmlink International, LLC

K-Number K203079

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KRD 2021-02-09

Concerto Versa, Detachable Coil

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K202850

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QEW 2021-02-09

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

Applicant Penumbra, Inc.

K-Number K210083

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FOZ 2021-02-08

HydroMID

Applicant Access Vascular, Inc.

K-Number K203069

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DZE 2021-02-08

Straumann 4 mm Short Implants

Applicant Straumann USA, LLC

K-Number K202942

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MWI 2021-02-06

MouthLab Vital Signs Monitoring System

Applicant Multisensor Diagnostics (Dba Aidar Health)

K-Number K201635

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POS 2021-02-06

SPEAC System

Applicant Brain Sentinel, Inc.

K-Number K200276

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CBK 2021-02-05

HAMILTON-C3

Applicant Hamilton Medical AG

K-Number K201306

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QIH 2021-02-05

LVivo Software Application

Applicant Dia Imaging Analysis, Ltd.

K-Number K210053

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MUH 2021-02-05

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

Applicant De Götzen S.R.L.

K-Number K203374

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DSH 2021-02-05

Carnation Ambulatory Monitor (CAM)

Applicant Bardy Diagnostics, Inc.

K-Number K210036

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PHX 2021-02-05

LINK Embrace Shoulder System - Reverse Configuration

Applicant Waldemar Link GmbH & Co. KG

K-Number K200368

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