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

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    FlexBand Plus

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

    Echo® Bi-Metric® Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868260582·

    ECHO BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304463400·

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989030228·ORTHOS CM TMA ARCH 019X025 LOSM PK10

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00840967190938·LUMBAR DTS GUIDE 12MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776205058·LLETZ Ring Fcp

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198437·AK3 Ultra Insert Trial Size 1, 12mm

    BD TUBE PMS PLH 13X100 3.5 PLBL LIM CE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 1, 2022

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107927·TRIAL 90-SRK-192112 POLY-MPCS 1X12 LEFT

    BTI DENTAL IMPLANT TINY 2.5-3.0

    FDA 510(k)
    FDA Class 2 ·Dental

    CRITICOOL PRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·October 7, 2008

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

    SPRINT QUATTRO

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 4, 2011

    MODULAR HEAD COMPONENT 32 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 26, 2017

    MODULAR HEAD COMPONENT 32 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 26, 2017

    G7 PPS LTD ACET SHELL 58G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·February 26, 2018

    Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·XTANT MEDICAL INC·February 6, 2019

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018