BEUDAMED
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    CATHETER 3-WAY SILICONE FOLEY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ceramill® Zolid

    FDA UDI
    Amann Girrbach AG·E4947602591·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110676·SILICONE SLEEVES PACK OF 6

    Straumann ZOLID-HT preshade

    FDA UDI
    Amann Girrbach AG·E494760259STM1·

    ZELTIQ CoolSculpting System

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

    DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLATE CHOCOLATE II AGAR 100 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSG·November 1, 2021

    PLATE CHOCOLATE II AGAR 100 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSG·August 11, 2021

    PLATE CHOCOLATE II AGAR 100 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSG·August 25, 2021

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 19, 2014

    SERIES 7000 STANDARD TIBIA

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·September 19, 2012

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 8, 2015

    PLATE CHOCOLATE II AGAR 100 EA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 27, 2022

    PLATE CHOCOLATE II AGAR 100 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSG·August 17, 2021

    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