9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAIR DRIVE, NEUTRACLEAR
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOPHOS XG DS/CEPH
FDA 510(k)
FDA Class 2
·Dental
SUPER CHAIR FOR KIDS BY ORION
FDA 510(k)
FDA Class 1
·Physical Medicine
JETSTREAM SC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011
CVC SET: 3-LUMEN 7FR X 2 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·August 22, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024