BEUDAMED
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    EMPOWR VVC TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197530248·Ferreira Style Breast Retractor 180x30...

    PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BMET ARCOM AP PAT W/WIRE 31MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 7, 2018

    NEEDLE 30GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 17, 2020

    VIDAS® CA 15-3 ASSAY

    FDA Adverse Event
    Injury ·BIOMERIEUX, S.A.·Product code LTK·July 5, 2018

    UNK GEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·December 19, 2018

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·July 22, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

    VECTRA GENISYS 2CH COMBO

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    ALARIS® SYRINGE MODULE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·October 24, 2018

    ALARIS® SYRINGE MODULE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·October 24, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    BD NEEDLE 30GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·September 12, 2019

    NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

    FDA Recall
    Terminated ·Ninepoint Medical Inc.·Product code NQQ·April 11, 2018

    BD NEEDLE 30GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·April 6, 2020

    BIOMET SPLINED KNEE STEM V2 WITH SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 12, 2019