21 results · 25ms · Sources: EU EUDAMED, 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