8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
FDA 510(k)
FDA Class 2
·General Hospital
AUST HELICAL SINGLE INCISION SLING
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·April 4, 2013
SOFTHEAT
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·March 30, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024