14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rainbow Shade
FDA 510(k)
FDA Class 2
·Dental
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674967·
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
EQUATOR PLUS ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
CPS/OSS 5CM TPR ADAPT W/OSS SC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 2, 2022
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008