BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    ENGAGE TR INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066510·

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50931300·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0131300·Rod Inserter, Articulating, MIS

    N LP(A) CONTROL SY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REGUTHERM 952 THERMOGRAPHIC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    OH PACK WITH VKMO 70000

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·August 21, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENENTT CORP.·Product code CBK·April 15, 2011

    MDLR CNLTD TRIDRV DRVR

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·August 29, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 21, 2023

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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