BEUDAMED
    20 results · 30ms · 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 ×

    IQ 200 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746077401·LIGATURE 20 STICK YELLOW 50/BAG

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156212·LIGATURE 20 STICK YELLOW 50/BAG

    JOSTRA ARTERIAL PERFUSION CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HRH-63 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 27, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    TENACULUM FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GCJ·March 28, 2008

    OT SURESTEP METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 31, 2011

    OT SURESTEP ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 11, 2011

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 14, 2010

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014