26 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASIR-V
FDA 510(k)
FDA Class 2
·Radiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606227·SPACER 2133640 OLIF25 27MM 18 DEG 18X40
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027704·
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
FDA 510(k)
FDA Class 2
·Dental
MIDMARK IQECG
FDA 510(k)
FDA Class 2
·Cardiovascular
U-BLADE SET, TI GAMMA3 10.5X100MM
FDA Adverse Event
Injury
·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 29, 2013
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 16, 2011
LOW PRESS BLACK MAX HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 1, 2014
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022
FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019
GMK SPHERE FEMORAL COMPONENT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019
3005180920-2018-00587
FDA Adverse Event
Injury
·July 31, 2018
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2017