BEUDAMED
    81 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 ×

    VPOD ITPR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIVID I DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LANX CERVICAL SA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 17, 2011

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 5, 2013

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·September 19, 2008

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 29, 2021

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 27, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 1, 2021

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 4, 2022

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KNS·July 19, 2021

    FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·January 11, 2021

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 29, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 20, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 3, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021