9,073 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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hyperion X5, NewTom GO, X-RADiUS COMPACT
FDA 510(k)
FDA Class 2
·Radiology
EONC
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 13, 2013
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·October 4, 2018
DERMABOND ADVANCED UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code MPN·November 15, 2018
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·December 26, 2019
STRATAFIX UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·December 26, 2019
STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·June 13, 2019
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 6, 2018
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 6, 2018
NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·April 6, 2018
NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·April 6, 2018
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 12, 2023
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·February 14, 2024
Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code OZP·November 15, 2023
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 29, 2026
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 29, 2026
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 29, 2026
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURER·Product code FWM·August 17, 2023
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 29, 2026
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 29, 2026