BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    UROSKOP OMNIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10193489586466·FINE SUTURE TRAY

    SleepWeaver 3D Mask and Large Headgear - Blue

    FDA UDI
    CIRCADIANCE, LLC·B036101491·SleepWeaver 3D Mask and Large Headgear - Blue

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111337727·MIXING/SOLUTION BOWL 1 5/8 QT

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556194·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501217·Gutta Percha Points is used to root canal filin...

    PLATE COLUMBIA CNA AG 5PRCT SB 90MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·June 20, 2023

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111272893·MIX/SOLUT BOWL 1 5/8 QT PK 12

    QUICKIE 2 POWER ASSIST WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HELIOSEAL CLEAR CHROMA

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    DUROM US ACETABULAR COMPONENT 48/42 H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 17, 2011

    Catalog SBA21MAHVJ, Sterile Major Abdominal Pack, Mfg date 5/22/03, Exp date 1/01/05, order 101491

    FDA Recall
    Terminated ·Cardinal Health·Product code LRO·June 27, 2003

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    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

    Model Number L210 PROPONENT SR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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