10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
FDA 510(k)
FDA Class 2
·Radiology
LEFORTE SYSTEM BONE PLATE & SCREW
FDA 510(k)
FDA Class 2
·Dental
PORTA OPTIMUM SOLDER 710
FDA 510(k)
FDA Class 2
·Dental
8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code MHY·February 28, 2023
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·May 21, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 26, 2014
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DRB·June 13, 2011
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025