BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CROSSLINKED POLYETHYLENE ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    GII OVAL RESURFACING PAT 32MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

    PARADIGM QUICK-SET INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PCCS GRAFT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECSYS T3

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·September 13, 2024

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013

    OTHER

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

    HAHN TAPERED IMPLANT 3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 29, 2020

    HAHN TAPERED IMPLANT 3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 20, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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