8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCHUHLI IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PARI RESPIRATORY EQUIPMENT, INC.
FDA registration
PARI RESPIRATORY EQUIPMENT, INC.·6 products·🇺🇸 United States
EXTEND TRACK UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
S80 IMPLANTABLE CARDIAC PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·February 11, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 24, 2014
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; 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 FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024