BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    COMPUDENT STA

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694017671·MFx Tag, Angulated Locking Safety Screw, 4mm

    NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHROCARE FLOW CONTROL UNIT

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

    E500 VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 16, 2013

    INVERTER/CHARGER BOARD ASS'Y

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·March 18, 2011

    PANOSCREEN I II & III

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 20, 2008

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Injury ·COOK INC·Product code EZN·May 21, 2019

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm .018" REF PMP8-6-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    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

    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

    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