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

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    BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559352·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559338·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01407N0·Cervical Rasp, 15 x 12, 7mm, 0 Degree, No Taper

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559321·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01407T0·Cervical Rasp, 15 x 12, 7mm, 7 Degree, Tapered

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559369·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559345·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559383·

    IRONMAN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033559376·

    D/C CORE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    TEKNIQUE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 11, 1997

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ACCENT DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    ELITE PASS SHUTTLE NEEDLE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code FMI·March 14, 2008

    ARTHREX CHONDRAL DART, 18MM

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code MAI·November 15, 2017

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024