42 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E-Temp
FDA 510(k)
FDA Class 2
·Dental
H.E.L.P.®
FDA UDI
B.Braun Avitum AG·04046964696770·HELP ULTRAFILTER HIPS 20 US
Repose Blue Cushion over EU 45cm
FDA UDI
Frontier Therapeutics Inc·05056279300889·Repose Blue Cushion over EU 45cm
WAVE
FDA UDI
SDI LIMITED·DO3682111011·
WAVE
FDA UDI
SDI LIMITED·09336472012977·WAVE HV 1 SYR B1
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111269·HALO, 1203-5 VEST PED4, COOLMAX LINER, 1211-1 L...
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·January 13, 2023
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·November 22, 2022
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 29, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 8, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·December 2, 2022
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·February 15, 2023
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·January 23, 2023
FREESTYLE LIBRE 3
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LTD·Product code QLG·March 9, 2023