BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD POSIFLUSH¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 29, 2019

    SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTADUR P 2, MODEL #2031

    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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    SYRINGE 5ML SALINE FILL CHINA SP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 10, 2019

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·May 3, 2011

    BARD FLATWIRE STONE BASKET

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC.·Product code FFL·July 24, 2008

    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