8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PathLoc-TA Expandable Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet Microfixation RibFix Advantage System
FDA 510(k)
FDA Class 2
·Orthopedic
AVANT LASER
FDA 510(k)
FDA Class 2
·Physical Medicine
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 21, 2011
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code OTP·July 9, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026