15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
FDA 510(k)
FDA Class 2
·Orthopedic
STATCORP MEDICAL
FDA UDI
Statcorp Medical·10841522102592·ABP CUFF,SPACELABS,1T,LARGE ADULT,SINGLE
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
Softcheck
FDA UDI
Statcorp Medical·10841522123863·ABP CUFF,SPACELABS,1T,LARGE ADULT,SPU,20/BX
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532420·Crossbar Acetabular Reamer - 42mm
REDSENSE-ALARM UNIT AND SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PITT-EASY DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 8, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011
GORE HELEX SEPTAL OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·September 5, 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