141 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Optimized Positioning System (OPS) Insight
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814565·GENUMEDI SAND SIZE V
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112748·BARRON VACUUM PUNCH 7.25MM
Unicondylar Sled Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575043972·Tibia Plateau,all-polyethylene
MESA Small Stature Spinal System
FDA UDI
VB Spine LLC·10888857186590·Threaded Hook Inserter, Inner Assembly
KENDRO HERACELL CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Neocis Guidance System (NGS) with Patient Splints
FDA 510(k)
FDA Class 2
·Dental
BD NEEDLE ECLIPSE 25X1 RB BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·September 22, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 18, 2024
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 11, 2025
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 2, 2024
FEMORAL COMPONENT SPHERE CEMENTED SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2023
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2023
ARTHREX FILPCUTTER FROM THE QUADLINK IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·ATHREX INC.·Product code MBI·January 27, 2025
STEM: QUADRA-P STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 20, 2023
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·BD SWITZERLAND SÀRL·Product code FPA·August 6, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2024
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 2, 2024
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2024
GMK-SPHERE 02.12.E0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2024