BEUDAMED
    14 results · 22ms · 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.

    P&P SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    n/a

    FDA UDI
    Ortho Development Corporation·00822409074273·10/12 Broach 14x19

    RCRP FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FRN·March 13, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·February 25, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Injury ·COOK INC·Product code EZN·May 21, 2019

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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