BEUDAMED
    21 results · 33ms · Sources: EU EUDAMED, US FDA

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    10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL

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

    POLARIS

    FDA UDI
    HNM TOTAL RECON LLC·00841742113395·POLARIS ø4.0mm/ø3.0mm High Compression Screw, C...

    MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM

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

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·May 23, 2011

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·August 18, 2014

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 19, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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