42 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
NA
FDA UDI
Richard Wolf GmbH·04055207012505·LITHOARM/SHORT
AORTIC OCCLUDER #000390
FDA 510(k)
FDA Class 1
·Cardiovascular
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520003900·Curved Ti Rod, 390mm
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 29, 2026
FlowLogic Agile
FDA UDI
SONENDO, INC.·00810209421144·FlowLogic Agile Shaping File Variable Kit, 21mm
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 27, 2025
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522131349·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,LONG,UKCA
CranialMask Tracker
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327097627·CranialMask Tracker
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129674·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,LONG
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 27, 2025
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·August 6, 2021
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·August 15, 2024
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 12, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 18, 2011
PFC SIG RPF CEM FEM SZ 3 LT
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·February 19, 2008
KINETIX?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·May 4, 2015
EVIS X1 VIDEO SYSTEM CENTER
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·August 27, 2024