8 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TINA-QUANT APOLIPOPROTEIN VER.2
FDA 510(k)
FDA Class 2
·Immunology
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·April 23, 2013
START-UP ACCESSORY KIT
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS HEALTHDYNE·Product code FLS·April 25, 2011
INTEGRITY SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018
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