BEUDAMED
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    MODIFICATION TO T2 RECON NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    ODYSSEY LX, MODEL 211320

    FDA 510(k)
    FDA Class 2 ·Radiology

    SF SH CATHETER, MODEL R65-945

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

    CROSS PLATE MTP, RIGHT ANCHORAGE

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·November 27, 2024

    VA LOCKSCR 2.4 SELF-TAP L20 TAN

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

    GUGLIELMI DETACHABLE COIL (GDC)

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code HCG·May 10, 2011

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·July 29, 2008

    CROSS PLATE MTP, RIGHT ANCHORAGE

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·November 25, 2024

    CROSS PLATE MTP, RIGHT ANCHORAGE

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·November 21, 2024

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

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

    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