37 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Locking device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)
PVS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
P3IMRT TM
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 2, 2021
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTL·October 14, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ABBOTT MEDICAL,·Product code DRC·March 6, 2026
AGILIS NXT INTRODUCER, UNKNOWN
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DYB·February 7, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·June 8, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·June 8, 2022
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 10, 2023
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·February 7, 2023
Y-90 THERASPHERE
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·August 21, 2024
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·February 7, 2023
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 28, 2023
UNKNOWN CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 8, 2023
FREEZOR MAX CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·January 24, 2023