13 results
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21ms
·
Sources: EU EUDAMED, US FDA
CLINPRO PROPHY POWDER
FDA 510(k)
FDA Class 2
·Dental
RD180® SP™
FDA UDI
LSI Solutions, Inc.·00850200006209·RD180® SP™ DEVICE
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 45cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022117·
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILICONE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
PROMUS ELEMENT ?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 16, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·March 24, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014