90 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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ELECSYS ANTI-TPO CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114025·HYDRO-DISSECT FLAT J-SHAPED 27GA (PK/10)
BIO-MET TYPE WIRE TWISTER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896082700·BIO-MET TYPE WIRE TWISTER
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551149408·ROSA STERILIZATION TRAY FOR SEEG 2.1MM DRILL BI...
3420 DIGIT PULSE OXIMETER, MODEL 3420
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOVITA PEEK SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·November 15, 2001
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 15, 2026
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 2, 2024
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·May 9, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·September 19, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·May 25, 2011
GMK-REVISION FEMUR REVISION PS SIZE 1 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 11, 2020
GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2023
GMK-REVISION FEMUR REVISION PS SIZE 6 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2021
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 31, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 12, 2020
GMK-REVISION - REVISION TIBIAL TRAY SIZE 2 RIGHT - FINISHING
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 23, 2024
GMK-REVISION FEMUR REVISION PS SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019