BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    1.5T OPTIMA MR430S

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828114844·GEN4 INTERACTIVE

    MILLER RASPATORY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896052451·MILLER RASPATORY DOUBLE ENDED REGULAR CUT SERRA...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551004738·REDUCING TUBE FOR GLOBUS BUSHING MODEL 2103-23

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828186292·GEN4 INTERACTIVE

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642129922·PS3 Tap, 8.0mm, NAV-M

    HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLID STATE X-RAY IMAGING DEVICES

    FDA 510(k)
    FDA Class 2 ·Radiology

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·April 3, 2015

    REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·June 17, 2022

    ACCU-CHEK ® ULTRAFLEX

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 9, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 25, 2011

    SYRINGE S2 20ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 8, 2021

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·May 5, 2016

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021