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    MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOSORB RESORBABLE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018

    AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 16, 2013

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 16, 2008

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 19, 2011

    NIM ECLIPSE SDNS32 MODE

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022