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

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    FIBIOCORE

    FDA 510(k)
    FDA Class 1 ·Dental

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496020431·VENERE 100, SIZE L, NERO, GRADUATED COMPRESSION...

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717104268·Stainless Steel H Files (Hand), Size # 25, Leng...

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·November 5, 2020

    ELRAN 01 SYSTEM

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

    LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

    NEXGEN CRUCIATE RETAINING FLEX FEMORAL

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·February 8, 2011

    BLAKE DRAIN UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GBX·February 3, 2021

    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical-Surgical Inc. Corporate Office·July 28, 2021

    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