15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER FLEXIBLE URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
FDA 510(k)
FDA Class 1
·Immunology
SENSAIRE DIAGNOSTIC SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·March 5, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 16, 2011
CYLOS DR-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·April 18, 2008
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016