BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2

    Intess L

    FDA UDI
    Kalitec Direct LLC·B07312K0100320·Assembly, Caddie, 30mm Lumbar Implants, Hinged

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400600320·Anterior Dome Osteotomy Guide, 60mm x 32mm

    SELOX SR 53

    FDA Adverse Event
    Other ·BIOTRONIK GMBH AND CO·Product code DTB·June 29, 2006

    SELOX SR 60

    FDA Adverse Event
    Other ·BIOTRONIK GMBH AND CO.·Product code DTB·June 29, 2006

    SEED SELECTRON MODEL V. 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEVEEN NEEDLE ELECTRODE

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

    LIFETEC ELITE V1.0

    FDA Adverse Event
    Malfunction ·IT SYNERGISTICS, LLC·Product code MMH·July 29, 2016

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 19, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011

    LAB-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·June 10, 2008

    ARIS TRANSOBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTN·September 9, 2021

    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

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022