8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RNP ANTIBODY TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
NA
FDA UDI
Richard Wolf GmbH·04055207044612·DRILL GUIDE FOR HOLLOW DRILL BIT SZ 9 for tibi...
HEMSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ETHYLENE OXIDE DETECTOR GLD-1-07
FDA 510(k)
FDA Class 2
·General Hospital
ACCUTRAK DELIVERY CATHETER SYSTEM
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code NPT·June 16, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024