11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Caremed Reusable & Disposable SPO2 Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Zimmer Persona Knee System
FDA UDI
Zimmer, Inc.·00889024471429·
Zimmer Persona Knee System
FDA UDI
Zimmer, Inc.·00889024471436·
TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 2, 2025
SILK'N FLASH N GO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOGICSCAN 64 LOGICSCAN 128
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
RELIANT STENT GRAFT BALLOON CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code DQY·June 23, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code MSF·September 4, 2008
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023