8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
n/a
FDA UDI
Ortho Development Corporation·00822409074204·10/12 Broach 12x19
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
FDA 510(k)
FDA Class 1
·Dental
PROTOCO2L INSUFFLATOR MODEL 6400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 9, 2013
DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code LDD·March 15, 2011
ENDOTAK DSP
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·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