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

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    MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESTENIA

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·April 29, 2013

    CODEMASTER XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code LDD·April 28, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNET CORP·Product code CBK·July 23, 2008

    Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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