BEUDAMED
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    MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810135030·PREMIUM DNT BASE LT FIBER HC 25 LB PAIL

    MASTER SWIVEL LYNX CLASSIC MOTOR

    FDA UDI
    MTI Precision Products, LLC·D8265013503·LYNX ETYPE 20000 RPM SWIVEL QUICK DISCONNECT LO...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105030·Implant Inserter, 8-10mm, Sleeveless

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981196639·Rod-to-Rod Connector, 3.5mm LG

    AMIGO WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    N LATEX CYSTATIN C

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Flexcera Base Ultra+ Light Pink

    FDA UDI
    Envisiontec GmbH·04260683220942·Flexcera Base Ultra+ is a light-curing material...

    NA

    FDA UDI
    aap Implantate AG·04042409071065·APS Plate 135°, 3 holes, L 62

    NA

    FDA UDI
    aap Implantate AG·04042409071072·APS Plate 135°, 3 holes, L 62

    Gibralt

    FDA UDI
    Choice Spine, LP·10885862145154·

    UNKNOWN ACETABULAR LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 20, 2013

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 3, 2011

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·March 10, 2008

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014