18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELTEX MEDICAL CARDIOQ-EDM+
FDA 510(k)
FDA Class 2
·Cardiovascular
NexxZr™ T / D-100-22-NT-C400-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113498·
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·May 7, 2009
COMPREHENSIVE LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
FDA 510(k)
FDA Class 2
·Hematology
THE CANARY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 12, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 22, 2008
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·May 28, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 21, 2016
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 16, 2020
MOSAIC MITRAL BIOPROSTHETIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·July 20, 2023
STAR S4 IR EX
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LZS·May 14, 2019
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 5, 2012
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 14, 2016
COBAS 6000 C501MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 13, 2008