BEUDAMED
    14 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 ×

    somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    MaxFuse,VBR, 12 (D) x 14 (W) x 30 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468056230·12 (D) x 14 (W) x 30 (H)

    COBRA SURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNGO TRUED SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PASSEO-18 5/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 6/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 2.5/170/130

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code OJX·June 7, 2013

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014