12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACIFIC PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ ST 98x12 ML C1
FDA UDI
ARGEN CORPORATION, THE·D818123358·Dental porcelain/ceramic restoration kit
Paxeon Logical
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570201297·Logical G-Series Shell – 3 Holes Size 58-D
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000905·
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052157·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111233580·58mm Acetabular Cup (3-hole)
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROMA (HE4 EIA + ARCHITECT CA 125 II)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089514088·
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 26, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 10, 2011