BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    SMART BAG MO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    QG-50-2

    FDA UDI
    CARESTREAM HEALTH, INC.·60889974000412·QG-50-2 X-RAY GEN 50KW 3 PHASE 208-240

    NA

    FDA UDI
    STERILMED, INC.·10888551018531·BUR CARBIDE ROUND 8 FLUTES

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854006603·ULTRAPOWER BUR, ROUND (LIME), 5 MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157077·

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 6, 2022

    INTRODUCER SHEATH

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

    CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

    FDA 510(k)

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·July 24, 2020

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 22, 2015

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 26, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 8, 2011

    QUICKSET 1PC FLEX DRILL BIT 5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·March 28, 2008

    STARDRIVE SCREWDRIVER SHAFT T8105MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWQ·November 28, 2016

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLE

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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