38 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SYNTHES MATRIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·January 18, 2016
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
5.5MM TI CURVED ROD 45MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027549·COPPER NITI 40 BAF16X22UP LG PK10
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152111·IN-OVATION® C Base Rx 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152611·IN-OVATION® C Roncone 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152101·IN-OVATION® C Base Rx 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152001·IN-OVATION® C Base Rx 022-U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152801·IN-OVATION® C EURO 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152811·IN-OVATION® C EURO 022 U5-5 CS-BC HK
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
SURGISIS GUIDED TISSUE REGENERATION MATRIX
FDA 510(k)
FDA Class 2
·Dental
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ACCELSTIM
FDA Adverse Event
Injury
·ORTHOFIX·Product code LOF·June 5, 2023
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013