BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOLLISTIM AQ Cartridge 300IU

    FDA UDI
    Merck Sharp & Dohme LLC·00300520313018·

    RAM® COR-SUTURE® QUICK LOAD®

    FDA UDI
    LSI Solutions, Inc.·00850200006827·RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 5MM, PLEDGE...

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 15, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 23, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 23, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 23, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 28, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 28, 2021

    NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REPROCESSED PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MUST MINI ROD TI 3.5 X 80MM (STERILE)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021

    HELICAL BLADE COUPLING SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code LXH·March 27, 2013

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC·Product code MGB·March 17, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 1, 2008

    COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015

    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 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