BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    2010 PLUS HOLTER FOR WINDOWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092127278·Multi-Unit Non-Engaging Titanium Base w/ Unigri...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092165256·Multi-Unit Non-Engaging Titanium Base w/ Unigri...

    Preat

    FDA UDI
    Preat Corporation·00842092174975·Multi-Unit Titanium Base w/Unigrip Screw Kit co...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135648·Multi-Unit Titanium Base w/Unigrip Screw (2)

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CRIT-LINE MONITOR III (CLM III)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    I-STAT ACT KAOLIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JBP·March 14, 2013

    UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSA·February 24, 2011

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·February 22, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016