9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTEGRAL AND POLYSTAR SELECTION
FDA 510(k)
FDA Class 2
·Dental
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305881·Diamond, cone round, medium grit
DIMENSION GARANT L, DIMENSION GARANT L QUICK
FDA 510(k)
FDA Class 2
·Dental
ELECSYSCA 15-3 II ASSAY
FDA 510(k)
FDA Class 2
·Immunology
TAXUS¿ LIBERTÉ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 2, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 9, 2011
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code LOJ·April 16, 2008
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Enforcement
Class II
·Terminated·superDimension, Inc·July 18, 2012
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