8 results · 29ms · Sources: EU EUDAMED, 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