10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Caiman Seal and Cut Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674561·
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
FDA 510(k)
FDA Class 2
·Radiology
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
MCA MED APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·July 6, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 7, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 6, 2014
QUADRA H CEMENTLESS FEMORAL STEM SIZE 5 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 11, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023