BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    ZOE MEDICAL INCORPORATED·00851920007187·ECG Intermediate Cable, 3-lead, 2 meter, IEC

    DORNIER COMPACT ALPHA LITHOTRIPTER

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

    PROLITE PULSED LIGHT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

    COMP AUG MINI BSPLT W TPR MD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·December 18, 2025

    NANOTACK SUTURE ANCHOR 1.4MM

    FDA Adverse Event
    Malfunction ·PIVOT MEDICAL·Product code MBI·March 19, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·March 16, 2011

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·March 27, 2008

    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