53 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
FDA Recall
Terminated
·Stelkast Co·Product code OQG·January 24, 2013
OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.
FDA Recall
Terminated
·Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342·Product code LGW·April 22, 2008
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013
GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code BSZ·March 12, 2010
GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code BSZ·March 12, 2010
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·GE Healthcare·Product code MQB·November 15, 2007
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LLZ·September 25, 2009
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·April 24, 2013
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Enforcement
Class II
·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013
GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·March 24, 2010
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·March 24, 2010
Innova 4100 / 4100 IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·March 6, 2008
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·October 21, 2011
AMX Navigate Mobile X-Ray System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·June 24, 2021
GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·November 4, 2008
GE Signa Advantage nuclear magnetic resonance imaging system.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code LNH·August 19, 2005
NOW RSV Test Item Number 430-430, Kit Number 430-00R
FDA Recall
Terminated
·Binax, Inc.·Product code GQG·February 18, 2004
Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code GQG·December 15, 2003
Prescription eyeglass safety lenses. Vision correction
FDA Recall
Terminated
·Eyemart Express Ltd·Product code HQG·September 12, 2014