12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccuCheck
FDA 510(k)
FDA Class 2
·Radiology
GelFlex Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238347·
DURALOC
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295107095·DURALOC SCREW-IN TRIAL LINER 32mm ID 74mm OD NE...
HL888
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYSTAND BANTAM MEDIUM
FDA 510(k)
FDA Class 2
·Physical Medicine
CERTAIN GOLD-TITE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
CERTAIN GOLD-TITE TM HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 11, 2024
IDENTITY XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
RAPID RHINO 752 EPISTAXIS DEVICE
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code EMX·August 18, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSD·February 22, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026