BEUDAMED
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    On Call Express Mobile Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLEA SPHERE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Z3D CONTRAST ACUITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 20, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 7, 2022

    GALAXY G3 XSFT HEL 2MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 8, 2019

    EXTRACTOR? PRO RX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code FGE·June 20, 2013

    ULTRAPULSE 5000C LASER

    FDA Adverse Event
    LUMENIS, INC.·Product code GEX·July 27, 2011

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·September 29, 2008

    OT PING METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2017

    Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    ACCUTREND ® TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CGA·May 3, 2019

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014