8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SPACELABS SERIES 600 PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDALL CURETTE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·October 10, 2017
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 19, 2014
ONYX LIQUID EMBOLIC SYSTEM
FDA Adverse Event
Malfunction
·EV3 ENDOVASCULAR, INC, CORPORATE WORLD HEADQUARTERS/PERIPHERAL VASCULAR·Product code MFE·October 21, 2010
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 4, 2012
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·March 16, 2022