9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXCEL FAST SET
FDA 510(k)
FDA Class 2
·Dental
GC Initial™
FDA UDI
Gc America Inc.·15400556708429·GC Initial™ Zr-FS Inside IN-44 Sand, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228751441·GC Initial™ Zr-FS Inside IN-44 Sand, 20g
TOURIQUET KIT WITH SNARE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IRON(IRN) TESTPACK, ITEM NO. 67659/95
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ONE-LINK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 11, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 19, 2010
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·October 24, 2013
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024