BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    CLEAN 'N' OIL

    FDA 510(k)
    FDA Class 1 ·Dental

    MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INLINE HANDLE WITH QUICK RELEASE AND SPORT GRIP

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·March 26, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR SWITZERLAND·Product code FGE·March 26, 2008

    BD ULTRA FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022

    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014