9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
HORIZON 1000 CARDIAC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515224858·Dautrey-Munro Osteo, 4mm, 6 1/4"
Tablo Console with Wireless Capability
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYRACT EXTRA RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
COBAS 8000 E 801 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 23, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
WALLFLEX¿ COLONIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MQR·November 29, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 28, 2010
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019