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

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    AltiVate® Anatomic Shoulder AG e+™ with Markers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code LHI·July 31, 2025

    CITIEFFE TITANIUM NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA S/5 WEB VIEWER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 22, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    ENDURON 10D 52OD X 32ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 12, 2011

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 9, 2013

    Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK

    FDA Recall
    Open, Classified ·American Contract Systems Inc.·Product code MLS·September 4, 2025

    Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023