21 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
FDA 510(k)
FDA Class 2
·Microbiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042277·CERA-CUT® Stevens Tenotomy Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042253·CERA-CUT® Stevens Tenotomy Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042260·CERA-CUT® Stevens Tenotomy Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042246·CERA-CUT® Stevens Tenotomy Scissors
curved...
CERANUM 82
FDA 510(k)
FDA Class 2
·Dental
APC FLASH-FREE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
CADD
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·November 21, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·March 13, 2020
THERATRON
FDA Adverse Event
Malfunction
·BEST THERATRONICS·Product code IWB·November 20, 2008
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 17, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·June 5, 2020
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 12, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·November 4, 2022
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 13, 2020
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019