BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    DADE TRU-LIQUID CARDIAC CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TILSON TRACH GUARD

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DROWZLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·January 20, 2026

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 22, 2013

    REALIZE ADJ GASTRIC BAND STR

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·January 31, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014

    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

    FDA Enforcement
    Class II ·Terminated·Ra Medical Systems Inc·August 6, 2014

    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 Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    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