8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SRT-100+
FDA 510(k)
FDA Class 2
·Radiology
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
MODIFICATION TO AURORA MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
ECHELON 60 ENDOPATH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2013
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 23, 2008
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024