8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
FDA 510(k)
FDA Class 2
·Dental
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984340·anteriors; shade B3; mould O 85
AMX-110, AMX-II AND AMX-III
FDA 510(k)
FDA Class 1
·Physical Medicine
PCI MODEL 2041-A TELEMETRY MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
FILTRATION INFUSION LINE BM25
FDA Adverse Event
Malfunction
·HAEMOTRONICS SPA·Product code FJK·February 10, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 6, 2014
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