12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MSFX MIKRON SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THD REVOLUTION
FDA 510(k)
FDA Class 2
·Radiology
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·September 14, 2018
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 19, 2008
U2 STRAIGHT LONG AM ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 2, 2011
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·July 22, 2013
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 13, 2019
BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019
BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019
BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 31, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025