13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OHMEDA MEDICAL OMNIBED
FDA 510(k)
FDA Class 2
·General Hospital
artegral life
FDA UDI
Merz Dental GmbH·D7091993407·anteriors; shade C4; mould BIM
ZQUIET MOUTHPIECE
FDA 510(k)
FDA Class 2
·Dental
Contour® next GEN Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·March 7, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·February 10, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016