12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Carnegie Surgical LLC
FDA UDI
Carnegie Surgical LLC·G14150638030·BARON suction tube 3 FR (1mm), with finger cuto...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312827·STD TRIAL CUP FOR BOACH Ø36+3
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·50699753462460·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037317488·STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +3
FLOWGUARD DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
GENERAL SURGICAL LAPAROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 28, 2013
FLEXIMA BILIARY STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·June 18, 2008
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 15, 2011
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