19 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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SOLANAS POSTERIOR STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Anterolateral Tibia Plate
FDA UDI
I.T.S. GmbH·09120047290019·Anterolateral Tibia Plate, 19-Hole, Right
Compressyn Staple
FDA UDI
DALLEN MEDICAL, INC.·00850815007097·
Compressyn Staple
FDA UDI
DALLEN MEDICAL, INC.·B470PEZ1311191·
MAYO CLINIC BC-10 1.5T
FDA 510(k)
FDA Class 2
·Radiology
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE REVERSE 38MM HUMERAL LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 7, 2022
Widex
FDA UDI
Widex A/S·05706069884784·WIDEX MOMENT MRR2D DEMO (Silver Grey ) 330, RC ...
Widex
FDA UDI
Widex A/S·05706069812480·Widex EVOKE E-PA (Silver Grey ) 330, RC coil
Widex
FDA UDI
Widex A/S·05706069920352·WIDEX MOMENT MBB3D 330 DEMO (Silver grey)
Widex
FDA UDI
Widex A/S·05706069886368·WIDEX MOMENT MRB0 (Silver Grey ) 330, RIC 10
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·May 23, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 16, 2011
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
BD MICROLANCE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 26, 2018
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026