41 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ST AIA-PACK PROG II Calibrator Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205819·
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225888·
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
FDA 510(k)
FDA Class 2
·Microbiology
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·February 12, 2018
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 13, 2018
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
TRILOGY EVO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 13, 2025
PELVICOL (BARD) 8CM X 12CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013
ANTHEM RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 28, 2011
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·June 16, 2014
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·September 15, 2015
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017