BEUDAMED
    11 results · 20ms · 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 ×

    SENOGRAPHE 600T AND 600TS SENIX HF

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO XYLOS SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    eKuore One electronic interface for stethoscope

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP.·Product code CBK·October 8, 2010

    UNKNOWN DEPUY CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 20, 2012

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·July 18, 2018

    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

    FDA Enforcement
    Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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