9 results
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18ms
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Sources: EU EUDAMED, US FDA
ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 1
·Anesthesiology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010065·Fixed, 4 electrode, HIS, 10mm electrode spacing
EASY.TOUCH INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
TERUMO U-100 INSULIN SYRING
FDA 510(k)
FDA Class 2
·General Hospital
RCSP RETROGRADE CANNULA
FDA Adverse Event
Injury
·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·November 12, 2010
MEDICAL UNKNOWN
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KOD·January 3, 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