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

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    W & H ASSISTINA

    FDA 510(k)
    FDA Class 1 ·Dental

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756000697·KNEE BRACE

    Intess C

    FDA UDI
    Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar

    ATTUNE CRS RP INSRT SZ 7 14MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code NJL·November 5, 2024

    KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 1, 2011

    SUPER MULTIVAC 50 WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·March 12, 2008

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NTE·March 4, 2011

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 11, 2020

    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·August 8, 2012

    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