BEUDAMED
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    SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMIX BONE GRAFT EXTENDER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO EBI SPINELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    16G X 1.16IN (1.7 X 30 MM) ANGIOCATH

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 30, 2019

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code MNH·April 17, 2013

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·June 18, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 14, 2011

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015