269 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
FDA 510(k)
FDA Class 2
·Dental
Back Sections
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761970182·Upper back section HV UK
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761980037·Trumpf Medical/Medizin Upper back section HV UK
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
FDA 510(k)
FDA Class 2
·Orthopedic
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 11, 2026
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 13, 2026
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·March 12, 2026
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 13, 2026
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 11, 2026
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2013
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 25, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 24, 2020
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·March 23, 2018
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·March 23, 2018
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·March 23, 2018
CERTAIN GOLD-TITE LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 4, 2026
CERTAIN GOLD-TITE LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 4, 2026
CERTAIN® TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·February 13, 2020