BEUDAMED
    14 results · 29ms · 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.

    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517597120·CoRoent Large MP Ti, 16x9x28mm 8°

    NOOSA Anterior Lumbar Plate Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215019884·

    SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONCORD 82

    FDA 510(k)
    FDA Class 2 ·Dental

    16.5MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·September 25, 2017

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

    LAMITRODE 44 SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 28, 2011

    18.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·July 24, 2017

    16.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·July 24, 2017

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·June 2, 2017

    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MQB·August 16, 2012

    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 19, 2012