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

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    EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK

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

    COR-KNOT®

    FDA UDI
    LSI Solutions, Inc.·00850200006278·COR-KNOT® MIS COMBO KIT

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380820·T-Handle, Ratcheting, Cannulated, Impact

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310020·Probe, 1.5 inch Ball, Steffee, Straight, Black

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

    TPO IGG ANTIBODY EIA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    COR-KNOT MIS COMBO KIT

    FDA Adverse Event
    Malfunction ·LSI SOLUTIONS, INC.·Product code HCF·November 20, 2024

    COR-KNOT

    FDA Adverse Event
    Malfunction ·LSI SOLUTIONS, INC.·Product code HCF·September 27, 2024

    COR-KNOT

    FDA Adverse Event
    Injury ·LSI SOLUTIONS, INC.·Product code GAS·October 5, 2018

    COR-KNOT®

    FDA Adverse Event
    Malfunction ·LSI SOLUTIONS, INC.·Product code HCF·October 22, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

    CAPTURA BIOPSY FORCEPS WITHOUT SPIKE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL, INC.·Product code FCL·March 16, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 17, 2014

    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

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012