13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
FDA 510(k)
FDA Class 2
·Microbiology
PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 28, 2022
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NPZ·May 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·May 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·May 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·May 28, 2010
LIBERTY CYCLER
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
2520274-2013-04024
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 2, 2013
2520274-2014-00718
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·February 21, 2014
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015