BEUDAMED
    18 results · 36ms · Sources: EU EUDAMED, US FDA

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    Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Temptation NOW® A2 76g

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003852·Crown and Bridge Temporary Resin

    Temptation NOW® A2 76g

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002059·Crown and Bridge Temporary Resin

    Low Profile Acetabular Reamer 52

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057558·

    DEFOGGING AND CLEANING SOLUTION- FLO-X

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

    VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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

    PINNACLE SECTOR II CUP 50MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 20, 2022

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 7, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 7, 2011

    PINNACLE SECTOR II CUP 50MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 26, 2024

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 30, 2017

    PINN SECTOR W/GRIPTION 48MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 18, 2021

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2016

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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