BEUDAMED
    16 results · 36ms · 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.

    ILLUMINA BEADXPRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066503·

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50931280·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450412510·

    NA

    FDA UDI
    STERILMED, INC.·10888551021319·BUR ROUND EXTRA LONG CARBIDE

    N LATEX LP(A)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO RELIEF BRIEF

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    KYPHX® HV-R? BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014

    KYPHX® HV-R? BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    SPACEMAKER PREPERITONEAL DIST BALLOON

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·September 10, 2014

    PTFE VASCULAR GRAFTS SOFT >=6MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DSY·April 15, 2011

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018