BEUDAMED
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    WBR XPRESS3.CARDIAC

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772778942·M4S PCL DYNAMIC LEFT XS

    Valencia Pedicle Screw System

    FDA UDI
    Altus Spine, LLC·00843210134635·Valencia Sterilization Case 1

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057370281·SKYTRON 2" SOFTCARE

    FortiFix

    FDA UDI
    NANOVIS SPINE, LLC·00814216026774·Nano FortiFix (S) case 1

    NaturaLyte

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101634·NaturaLyte Liquid Acid Concentrate for Bicarbon...

    ALPCO MILENIA ANTI-TPO ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    ADULT HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 15, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 26, 2013

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

    AED PLUS

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORP·Product code MKJ·July 21, 2008

    PALINDROME 23/40 KIT W/ SLOT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·June 11, 2014

    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.

    FDA Enforcement
    Class I ·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012

    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·March 29, 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