28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIATRON PICTUS 400
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Hader
FDA UDI
Preat Corporation·00842092175415·Hader Combo Kit. Kit contains . 2 Hader Metal H...
Spark TruColor
FDA UDI
METREX RESEARCH, LLC·00615375013236·FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, NORTH AME...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111375583·INST TRAY 6.875 X 6.375 X 4
Sklar®
FDA UDI
SKLAR CORPORATION·30649111288757·INST TRAY 6 7/8X6 3/8X4 PK 6
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRIT-LINE MONITOR III TQA (CLM TQA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 3, 2013
NATURA LPC WAFER, 57MM DURAHESIVE CMT, 22-33M
FDA Adverse Event
Injury
·CONVATEC INC·Product code EXE·September 15, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·May 10, 2011
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 30, 2023
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MGB·April 4, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 22, 2025
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024