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

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    SoloAsisst II, Voice Control

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

    StarDental Instrument Solutions

    FDA UDI
    DENTALEZ, INC.·D7022004730·CLASSIQUE DIA INSTRUMENTS 772-8P

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003180·Diagnostic EP Catheter, Josephson curve, 4 elec...

    K-Wire

    FDA UDI
    Treace Medical Concepts, Inc.·00810111227148·K-Wire

    GOELETE RETRACTOR 7-1/2" DOUBLE ENDED 40mm x 40mm & 30mm x 30mm

    FDA UDI
    W.H. Holden, Inc.·D9282004730·

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457205630·Conical Bl

    AugMENTA Penile Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Stone Retrieval Balloon

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    QUADRA P FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 30, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·February 29, 2024

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    FDA Enforcement
    Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021