BEUDAMED
    16 results · 24ms · 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 ×

    REMSTAR PLUS CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    M-SERIES DC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743519·LEVAMED ANKLE SUPPORT SILVER III

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036007140·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023963·PADDLE SPREADER, 13MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102130·Shaver, Open 13mm

    GO MEDICAL BALLOON INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040

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

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·March 12, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 1, 2011

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013