84 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LINQ II Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569196·CoRoent Ant TLIF Ti, 11x11x30mm 4°
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003195·Luna Opal R Mini .018 UR2 (+8°T +9°A)
Comprehensive SRS
FDA UDI
Biomet Orthopedics, LLC·00880304714809·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551135852·HALO, 1203-5 VEST X-LARGE, ACRYLIC LINER, 1211-...
OPTIMA XR120
FDA 510(k)
FDA Class 2
·Radiology
OB-1 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2025
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·October 29, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·August 3, 2011
STERRAD 200, SINGLE DOOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 8, 2013
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2024
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2025
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 13, 2025
GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 10, 2023
GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 17, 2024