10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAO-HOTPACK
FDA 510(k)
FDA Class 1
·Physical Medicine
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000885199·INSTRUMENT 9790904 PLATE HOLDING PIN
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902989551·INSTRUMENT 9790904 PLATE HOLDING PIN
LEONE SPA
FDA UDI
LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue
CLEANING AND ISOLATION ROOM KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Conformis BeneFIT Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
LAMITRODE 44 PADDLE LEAD
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024