BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    ASTRA SYSTEMS CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209123186·KIT, MEDIC RR

    MONTAGE XT Cranial Cement

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDCARE SUTURE REMOVAL TRAYS

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 16, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·December 3, 2012

    RF MULTIGEN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·September 7, 2010

    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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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