8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cambridge Partial Knee Tibial Component, RMLL - C, 9
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215146139·
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
FDA 510(k)
FDA Class 2
·Hematology
INFINITY MASIMO SET SP02 POD
FDA 510(k)
FDA Class 2
·Cardiovascular
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 11, 2014
PORTEX D.I.C. TRACHEOSTOMY TUBE 8.0MM
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·September 14, 2011
LUMAX 740 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NIK·August 2, 2013
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024