7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SI-Cure Sacroiliac Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
MULTIPLE NAME
FDA 510(k)
FDA Class 1
·General Hospital
FIBERFILL SGP
FDA 510(k)
FDA Class 1
·Dental
QUICKSITE XL LV
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
ULTRAVAC 90 WITH INTEGRATED CABLE
FDA Adverse Event
Other
·ARTHROCARE CORPORATION·Product code GEI·August 18, 2011
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026