29 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
FDA 510(k)
FDA Class 2
·Cardiovascular
Zethon
FDA UDI
ZETHON LIMITED·05060528013376·HDS-121 - HEKADRILL HANDPIECE - ELECTRIC
ORTHOPILOT
FDA 510(k)
FDA Class 2
·Neurology
OPTIBOND SE
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® GUIDE
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code LFR·October 9, 2025
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALUE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2011
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
PRIM SYM SET2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
PRIM SYM SET 2 CL W/ FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FPA·January 16, 2012
PRIM SYM 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025