24 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OEC Elite
FDA 510(k)
FDA Class 2
·Radiology
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
REMEL SPECTRA VRE
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 4, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
NC SPRINTER RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code LOX·July 20, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2020
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 12, 2018
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 19, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 16, 2020
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·August 15, 2019
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 4, 2019