BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    THERMODILUTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044206708·5" CHROM COLUMN MED FILTER

    SHARGHP A.V. FISTULA NEEDLE SET

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

    VERSALINK TITANIUM ROD-TO-ROD COUPLERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    PROFILE BIABUT 4.0 -Ø5.5

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

    MAVERICK2 MONORAIL PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·July 28, 2008

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024