14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GORE® PROPATEN® Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
LCP
FDA UDI
Synthes GmbH·10886982164889·3.5MM LCP(TM) PILON PLATE 9 HOLES
Sapphire NC Plus
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955916915·Percutaneous Transluminal Coronary Angioplasty ...
SYNTHES EXTERNAL MIDFACE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023