11 results
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21ms
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Sources: EU EUDAMED, US FDA
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
COLORMATE TLC BILITEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MP-3C POWER BASE CHAIR, MODEL MP3C
FDA 510(k)
FDA Class 2
·Physical Medicine
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·April 2, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 28, 2011
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·April 18, 2008
IRIDEX IQ577 LASER SYSTEM
FDA Adverse Event
Injury
·IRIDEX CORP.·Product code GEX·November 4, 2013
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