BEUDAMED
    17 results · 21ms · 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 ×

    POWERPICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843842·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE MEDIUM...

    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·June 12, 2019

    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS

    FDA Recall
    Terminated ·Accuray Incorporated·Product code IYE·April 10, 2018

    Neocis Guidance System

    FDA UDI
    NEOCIS INC·00810004900059·Anterior Fiducial Array, LLUR

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389027998·FENESTRATED DRAPE, 24 X 30

    Phonak Virto I70-Titanium

    FDA UDI
    Sonova AG·07613389627046·

    IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B

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

    N PROTEIN STANDARD UY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 6, 2025

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 11, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 28, 2008

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2021

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 7, 2021

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2021

    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