7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICRORATE INTELLIGENT PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 6, 2013
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 9, 2010
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·July 7, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024