8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BC PLUS
FDA 510(k)
FDA Class 2
·Dental
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AVIATOR ASSY TWO LEVEL PLATE SIZE 28
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016
RADIFOCUS INTRODUCER II KIT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·April 9, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 28, 2011
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
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