BEUDAMED
    16 results · 19ms · 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.

    RENEAU UNIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Spoon Excavator 840-841-842

    Device
    EU MDR · Eu Md Class 1 ·Medspo·On the market·2 countries

    TRACE MODEL #'S 840, 841, 842, 845

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TABLO CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Merlin Mount, L 820/840/841/844

    FDA UDI
    VOLK OPTICAL INC.·00811608019635·

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·January 2, 2024

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 30, 2014

    P.F.C.* LINER54-58/0DEG-28

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code LPH·November 20, 2012

    RX HERCULINK 14 STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·September 17, 2010

    Spoon Excavator 840-841-842

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Medspo·1 device

    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016

    DRX Revolution Mobile X-Ray System

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