14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL MES-9000/EMG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021569049·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021569018·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021569025·
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2025
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 10, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008
FEMORAL STEM 12/14 NECK TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 2, 2021
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