BEUDAMED
    26 results · 22ms · Sources: EU EUDAMED, US FDA

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    CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502122·Gutta Percha Points is used to root canal filin...

    SHIMADZU COLLIMATOR R-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROSTIVA RF THERAPY MODEL 8929 HAND PIECE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    V8 TRANSLUMINAL BAV CATHETER

    FDA Adverse Event
    Death ·INTERVALVE INC.·Product code OZT·June 19, 2014

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·August 27, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

    INCLUSIVE TAPERED IMPLANT 5.2 MMD X 8 MML X 4.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 6, 2022

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    THROMBUSTER II

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019

    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Model Number U128, VALITUDE CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021