22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISCOVERY FACET SCREW FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440940·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440957·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440933·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440971·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440964·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033440988·
NEUROMAP WITH NEURO 100
FDA 510(k)
FDA Class 2
·Neurology
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
ACTIVA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·November 19, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 29, 2015
BILATERAL DOUBLE BALLOON SET
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 30, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 13, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 20, 2013
SIEMENS BRAND NAME
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·March 2, 2011
COOL-TIP RF SYS 100V ENG
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 12, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 6, 2015
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 6, 2015
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