10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ArcScan Insight 100
FDA 510(k)
FDA Class 2
·Radiology
INSIGNIA WITH ITERO
FDA 510(k)
FDA Class 2
·Dental
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
AMISTEM H HA COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 19, 2022
STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1 LOT. 153416
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 10, 2022
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 7, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023