11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
FDA 510(k)
FDA Class 2
·Physical Medicine
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488750699·STERILE CIRCUMCISION PK
HERACERAM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MWI·September 9, 2010
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·September 9, 2010
SYBQ 2 CHANNEL V2.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·February 24, 2011
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023
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