BEUDAMED
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    SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302730531053·Young Prophy Cup, Soft, Long, Gray Spiraled Tur...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844863·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE EXTRA ...

    CarePoint Precision

    FDA UDI
    ALLISON MEDICAL, INC.·00786227053257·3ml Luer Lock Syringe w/ 20G x 1.5"

    EasyDrip ReadyGard Duo Safety Pen Needles 31G 5mm

    FDA UDI
    Sandstone Medical (Suzhou) Inc.·16972857293014·

    Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm

    FDA UDI
    Sandstone Medical (Suzhou) Inc.·16972857293342·

    Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm

    FDA UDI
    Sandstone Medical (Suzhou) Inc.·16972857293601·

    ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOSPHERE MEDICAL INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 11, 2013

    OPTIFLEX 180 NR

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·May 21, 2008

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 13, 2011

    Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018