35 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF
FDA UDI
Thoratec Corporation·00813024010807·
Oticon
FDA UDI
Oticon A/S·05707131189738·K140, ITC P PB DIR L BE
FlexStep
FDA UDI
Liftup A/S·05714420033931·FlexStep V2, 900, 4 steps, Outdoor
DENTAL ELEVATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896053069·DENTAL ELEVATOR #301
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXILLARY DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·February 15, 2023
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 23, 2012
INTERSTIM
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code EZW·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
ACCUSTICK II
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DYB·May 11, 2011
DELTAFILL10 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
GALAXY G3 8MM X 24CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
DELTAFILL10 2MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
GALAXY G3 4MM X 12CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
GALAXY G3 8MM X 24CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
DELTAFILL10 2MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022