19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RE / STASIS (TM) GINGIVAL RETRACTION PASTE
FDA 510(k)
FDA Unclassified
·Unknown
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564108·CoRoent Ant TLIF PEEK, 11x11x34mm 8°
BD PLASTIPAK 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·August 7, 2023
BD PLASTIPAK 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·August 7, 2023
BD PLASTIPAK 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·August 7, 2023
BD PLASTIPAK 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·August 7, 2023
PHASE II GBM IGG ANTIBODY EIA TEST
FDA 510(k)
FDA Class 2
·Immunology
AGACHAMBER SPACER
FDA 510(k)
FDA Class 2
·Anesthesiology
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 13, 2020
BD PLASTIPAK¿ 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 15, 2023
BD PLASTIPAK¿ 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 18, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 9, 2020
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 25, 2023
ACRYSOF TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 9, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 23, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 13, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025