7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOANCHOR AND OPENANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
MAXI 500
FDA Adverse Event
Injury
·BHM MEDICAL, INC.·Product code FSA·November 24, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015