BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    Straight Arm DDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mediant Anterior Cervical Plate

    FDA UDI
    INTELLIGENT IMPLANT SYSTEMS, LLC·00814033021174·Mediant 4.0 x 12 mm Bone Screw

    STEALTH™ Anterior Cervical Interbody Spacer

    FDA UDI
    Choice Spine, LP·00840996129312·STEALTH,TRIAL,12X14X12,0 DEG

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113621·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

    Orfit Industries

    FDA UDI
    Orfit Industries NV·05420028711408·Secondary Base Plate

    STEALTH™ Anterior Cervical Interbody Spacer

    FDA UDI
    Choice Spine, LP·00840996100441·STEALTH,SPACER,12X14X12,0 DEG

    Fuji Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41712140121·4.0mm Variable Angle Self Tapping

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193114538·HA PEEK EVOS Straight, ,12mmx9mmx 22mm , FLAT 5...

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100717·VBR,SPACER,12X14X12,0 DEG

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020527·FPS 4.0mm x 12mm Standard Screw

    DOC BAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFILL OBLIQUE TLIF DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074704·FPS 4.0 x 12mm Screw Sterile Qty 2

    UNKNOWN DEPUTY TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·October 27, 2008

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 17, 2011

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 3, 2013

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014