8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POTATO DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
TCAT (R) THA Instrument Tray Set
FDA 510(k)
FDA Class 2
·General Hospital
DINAMAP MODEL 850
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 13, 2010
2CM PERIPHERAL CUTTING BALLOON¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·December 19, 2012
HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 30, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024