BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    OPTICAGE INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131234834·K50, ITC P DIR R BE KIT

    Tobii Dynavox

    FDA UDI
    TOBII DYNAVOX LLC·07340074601929·SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iP...

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003273·65 V2 SMALL 22OD ELBOW W/HG

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104813·PS3 Screw 5.5mm x 25mm

    MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERCISE CARTESIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·December 13, 2024

    HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 26, 2025

    HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 27, 2024

    HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 21, 2023

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    TIBIAL RESECTION GUIDE MODULAR CAPTURE RT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Injury ·GE HEALTHCARE·Product code MHX·June 1, 2011

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021