10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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D-DIMER WELLCOTEST (HA10)
FDA 510(k)
FDA Class 2
·Hematology
PAQ.152X100X160.NEOVENTA
FDA UDI
AB MEDICA GROUP, S.A.·08428763009245·
COAGULATION REFERENCE PLASMA, NORMAL
FDA 510(k)
FDA Class 2
·Hematology
TEGWIRE (TM)
FDA 510(k)
FDA Class 2
·Cardiovascular
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·June 25, 2015
ADAPTOR FOR ABL5
FDA Adverse Event
Other
·RADIOMETER MEDICAL APS·Product code CHL·March 22, 2006
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 2, 2010
RESOLUTE INTEGRITY
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code NIQ·December 20, 2012
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