BEUDAMED
    13 results · 12ms · Sources: EU EUDAMED, US FDA

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    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MNH·March 6, 2009

    Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JDW·January 23, 2009

    Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LZY·January 12, 2009

    Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·July 6, 2009

    Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·July 6, 2009

    Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code MRC·October 30, 2009

    Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·July 6, 2009

    Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·July 6, 2009

    Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002

    FDA Recall
    Terminated ·Sybronendo·Product code EKM·October 27, 2009

    St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA

    FDA Recall
    Terminated ·St. Jude Medical Atrial Fibrillation Division Inc·Product code OCL·June 15, 2009

    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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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