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

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    PTA AND PTV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

    FDA 510(k)
    FDA Class 2 ·Hematology

    DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUMMIT CEMENTED STEM SZ2 STD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 27, 2013

    GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM

    FDA Adverse Event
    Malfunction ·GENDEX DENTAL SYSTEMS·Product code EHD·March 17, 2011

    ACUJECT VARIABLE INJECTION NEEDLE (DEVICE 1 OF 2)

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code GAA·March 26, 2008

    OT SURESTEP METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 31, 2011

    OT SURESTEP ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 11, 2011

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 14, 2010

    BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIOMATERIAL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 2, 2022

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 3, 2018

    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