32 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
FDA 510(k)
FDA Class 1
·General Hospital
Tizian Blank 5.0
FDA UDI
Pritidenta GmbH·04251366906260·
priti®multidisc ZrO2
FDA UDI
Pritidenta GmbH·04251366905225·
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
FDA 510(k)
FDA Class 2
·Orthopedic
STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 28, 2026
QT SCANNER 2000 MODEL A
FDA Adverse Event
Injury
·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 4, 2026
IMAGIQ
FDA Adverse Event
Malfunction
·STILLE SURGICAL·Product code KXJ·November 4, 2008
SENSIA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·August 23, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc·December 21, 2016
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 2, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 30, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
130° RADIOLUCENT TARGETING ARM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·August 12, 2024
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 3, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 21, 2025
ARCHITECT CMV IGG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·February 19, 2026