171 results
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Sources: EU EUDAMED, US FDA
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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
Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
FDA Enforcement
Class II
·Terminated·Remel Inc·August 19, 2015
Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
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
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·August 7, 2019
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 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
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
FDA Enforcement
Class III
·Terminated·GE Healthcare, LLC·July 3, 2019
GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUE·October 17, 2011
Advantx-E is an angiographic X-Ray system.
FDA Recall
Terminated
·GE Healthcare·Product code IZI·January 14, 2008
Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·January 14, 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