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

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    NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SureLOK Mini Posterior Cervical/Upper Thoracic System

    FDA UDI
    PRECISION SPINE, INC.·00840019907637·3.5mm x 6.25mm Inline Domino

    SureLOK Mini Posterior Cervical/Upper Thoracic System

    FDA UDI
    PRECISION SPINE, INC.·00840019907569·3.5x3.5mm Inline Domino

    SureLOK Mini Posterior Cervical/Upper Thoracic System

    FDA UDI
    PRECISION SPINE, INC.·00840019907439·3.5x4.5mm Inline Domino

    SureLOK Mini Posterior Cervical/Upper Thoracic System

    FDA UDI
    PRECISION SPINE, INC.·00840019907620·3.5x5.5mm Inline Domino

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

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

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    MITEK ABSORBABLE ANCHOR IMPLANT

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MAI·April 8, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 23, 2011

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP, FORMERLY US SURGICAL·Product code FZP·August 6, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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 Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013