164 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009
Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code MHX·July 23, 2009
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
FDA Recall
Terminated
·GE Healthcare·Product code IOL·February 16, 2015
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
FDA Recall
Terminated
·Cook Inc.·Product code KRA·November 8, 2019
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
FDA Recall
Terminated
·Cook Inc.·Product code KRA·November 8, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
FDA Recall
Terminated
·Cook Inc.·Product code KRA·November 8, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
FDA Recall
Terminated
·Cook Inc.·Product code KRA·November 8, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 18, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 18, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 18, 2019
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 18, 2019
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·March 19, 2013
IVEA Product Part Number 16100 Model 500A
FDA Recall
Terminated
·Firefly Medical, Inc.·Product code FOX·August 24, 2017