71 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
NexxZr™ / W-98-25-UT-D400-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139917·
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551149422·STEALTH STERILIZATION TRAY FOR SEEG 2.1MM DRILL...
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASPIRE COVERED STENT AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 15, 2026
POWERPACK
FDA Adverse Event
Malfunction
·ICC-NEXERGY·Product code IYN·September 3, 2013
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2025
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
PROTECTA DR
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LWS·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
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
GMK-REVISION FEMUR REVISION PS SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 26, 2022