9 results
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20ms
·
Sources: EU EUDAMED, US FDA
ARIA RADIATION ONCOLOGY WITH MIRS
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO SYNTHES (USA) POLYPIN
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 6, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·April 5, 2011
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·May 7, 2019
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 14, 2017
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