18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Syneron CO2RE System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Neuro Cochlear Implant System
FDA UDI
NEURELEC·03663227001815·PACKING SET, NEURO2 ZTI EXCHANGE BOX C092
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 7, 2023
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664911785·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664944882·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664907849·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664944820·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664900963·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664907900·
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664907726·
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 17, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
CRE BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KNQ·September 25, 2008
BD LUER-LOK¿ TIP DISPOSABLE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 17, 2021
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·July 17, 2025
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018