23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO YASARGIL ANEURYSM CLIPS
FDA 510(k)
FDA Class 2
·Neurology
Portex
FDA UDI
ICU MEDICAL, INC.·15019315083358·
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496002871·NAOMI 30, SIZE XL, BLU SCURO, GRADUATED COMPRES...
INVACARE LIFT CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 6, 2025
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 19, 2024
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·February 28, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
M2A 38MM ONE-PIECE CUP 38MM X 58 O.D.
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 20, 2012
M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·March 20, 2012
TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code NTG·February 4, 2022
DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·February 4, 2022
TALAR COMPONENT SIZE 5 RIGHT GREEN FOR USE WITH SIZE 5 TIBIAL COMPONENTS ONLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·February 4, 2022
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 19, 2024
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 19, 2024
SCREW
FDA Adverse Event
Injury
·BIOMET 3I·Product code HWC·April 5, 2019
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013