7 results
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18ms
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Sources: EU EUDAMED, US FDA
OSTEOTOMY DRAINAGE TUBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRESSIO ICP MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
VersaOne Bladeless Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 8, 2010
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·December 10, 2012
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