14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BSD3543W
FDA 510(k)
FDA Class 2
·Radiology
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055728·METZENBAUM SCISSORS DELICATE CURVED BLADES POWE...
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964091865·Endo Carry-On Procedure Kit
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964109522·The ENDO CARRY-ON Procedure Kit contains all of...
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERDICT-II PROPOXYPHENE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·July 29, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 1, 2013
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021