36 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PlaDuo System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HHM
FDA UDI
Oticon A/S·05707131351739·G300 SC, BTE PP 13 2.4G 105 C093 HHM
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750005642·QUEST LG REPLMNT FACE PC A7031
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001935·CODMAN SLIM-LINE Aneurysm Clip Bayonet Blade Le...
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063297·Ti ILIAC BONE SCREW ASSY, 8.5mm X 35mm X 30°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063280·TI ILIAC BONE SCREW ASSY, 8.5MM X 35MM X 15°
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
FDA 510(k)
FDA Class 2
·Cardiovascular
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 20, 2017
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 20, 2023
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 31, 2019
TALENT AAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 31, 2019
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 31, 2019
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 31, 2019
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 27, 2014
ACROBAT-I STABILIZER
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·December 21, 2018
Colonoscope, Model Number PCF-H190L.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024