BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500750·Pedicle Marker, Inserter

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136872·Ti-6Al-4V ALIF Implant 30 X 26, 13mm Height 22°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136902·Ti-6Al-4V ALIF Implant 30 X 26, 19mm Height 22°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136896·Ti-6Al-4V ALIF Implant 30 X 26, 17mm Height 22°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136889·Ti-6Al-4V ALIF Implant 30 X 26, 15mm Height 22°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136919·Ti-6Al-4V ALIF Implant 30 X 26, 21mm Height 22°...

    ACE BIO WIN TIBIAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UF BRACHYTHERAPY STAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

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

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 19, 2011

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·June 18, 2008

    MDLR CNLTD TRIDRV DRVR

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·August 29, 2023

    Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020

    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 30, 2016

    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015