BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bausch + Lomb

    FDA UDI
    Bausch & Lomb Incorporated·00757770405848·MIDDLE FOSSA DURA RETRACTOR

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776177232·PEDERSON VAG SPEC SM RIGHT SIDE OPEN

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·February 26, 2014

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNTHES USS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·September 1, 2015

    RIA DRIVESHAFT L520

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·March 24, 2014

    LAG SCREW, STST 10.5X95MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 21, 2010

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·July 21, 2011

    7.5CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 14, 2014

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024