7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PINNACLE3 APEX
FDA 510(k)
FDA Class 2
·Radiology
Leva Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013