9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELITONE Urge Urinary Incontinence Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ryno Lacer Wrist and Thumb Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238842·
MODIFICATION ORIA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable EEG cable
FDA 510(k)
FDA Class 2
·Neurology
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 18, 2011
TOTALCARE SPORT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 2, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026