BEUDAMED
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    ORTHO-PRO CANNULATED BONE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994325761·CONNECTOR 7042310 LAT CONN TI 5.5 12MM

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496042310·ALISEA 70, SIZE XL, NERO, GRADUATED COMPRESSION...

    Bard® Dimension® Stone Basket

    FDA UDI
    C. R. Bard, Inc.·00801741066801·Bard® Dimension® Stone Basket

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871685·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    CARDIOBEEPER CB12/12, MODEL CB12/12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSEETTE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·April 3, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 15, 2011

    CONTAK RENEWAL 3

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    ASCENT PS TIB BEARING 24X79/83

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 31, 2018

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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