BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Nanox.ARC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111217739·SUT SCISS DEL SHRTBENT 3 1/2

    SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY MITEK FULLY ABSORBABLE ANCHORS

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MAI·August 7, 2007

    FULLY ABSORBABLE ANCHORS

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MAI·August 7, 2007

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 4, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·July 15, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 12, 2013

    X-TEN

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·June 27, 2019

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    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

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026