11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Salvo® Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
FDA 510(k)
FDA Class 2
·Orthopedic
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·February 25, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
SERVO-U
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·September 10, 2019
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008
ECHELON*FLEX45 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025