9,073 results · 33ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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