10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAMPYLOBACTER CVA AGAR
FDA 510(k)
FDA Class 1
·Microbiology
GE DATEX-OHMEDA ENGSTROM CARESTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
AirStrip RPM
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXIMO II CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 6, 2012
INDUCTOS
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·June 12, 2014
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012