75 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776303136·Virgin Pederson Vaginal Speculum, 9mm x 3"
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK
ORLOCATE SYSTEM MODEL ORL 100
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·SANMINA-SCI SYSTEMS·Product code DQA·October 14, 2014
TOTALCARE BED
FDA Adverse Event
Other
·HILL-ROM, INC.·Product code FNL·June 6, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 21, 2011
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 11, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·April 29, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 19, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 21, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 20, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 25, 2021
(17-0551) ANKYLOS C/X IMPLANT B6.6
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 20, 2021