BEUDAMED
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    VISUM LED SURGICAL LIGHTING SYSTEM

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159778·PROTECT.LEVA ANKLE SUPPORT GRAY II

    FITLIFE

    FDA UDI
    Respironics, Inc.·00606959004122·FitLife Mask with Headgear, Large, US

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496060802·POWER UNISEX, SIZE S, BLU TONIC, ANATOMIC COMPR...

    MATIRA ANTERIOR CERVICAL SYSTEM

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

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742112367·LYNX Olecranon Locking Plate, Anatomical, Ti - ...

    Durable BP Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935104919·

    CARDIAC VIEW, MODEL 2001

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPIRAL IMAGING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    EMAX2PLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    11.0 CM LONG ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 5, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 6, 2014

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·June 12, 2008

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    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