17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infinitt RT PACS
FDA 510(k)
FDA Class 2
·Radiology
EarQ
FDA UDI
Oticon A/S·05707131343796·G10, MINIRITE 312 2.4G C092 EARQ
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LAKONG ULTRASONIC SCALER
FDA 510(k)
FDA Class 2
·Dental
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
BARD
FDA Adverse Event
Injury
·BARD MEDICAL DEVICE·Product code LJT·June 20, 2013
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 8, 2008
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
ULTRATHANE SUPRAPUBIC CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KOB·August 23, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·July 21, 2021
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·May 1, 2019
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 14, 2023