18 results · 20ms · Sources: EU EUDAMED, US FDA

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LaserME

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

XLIF

FDA UDI
Nuvasive, Inc.·00887517193100·XLIF Corpectomy Rib Dissection Tool

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925019478·HOUSE TYPE MALLEUS NIPPERS

Cuff Set, XX-Large

FDA UDI
VASOMEDICAL, INC.·00817980020979·Cuff Set, XX-Large

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 3, 2012

KINETRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 5, 2013

GISH TUBING AND CONNECTORS WITH GBS COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

REMSTAR SE

FDA 510(k)
FDA Class 2 ·Anesthesiology

Widex

FDA UDI
Widex A/S·05706069914771·WIDEX MOMENT MRB2D (Shocking pink ) 330, Teleco...

Widex

FDA UDI
Widex A/S·05706069827590·WIDEX EVOKE EBB3D (Shocking pink ) 330, Telecoi...

Widex

FDA UDI
Widex A/S·05706069691948·Widex BEYOND B-F2 (Shocking pink ) 330, Telecoi...

DORMA 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 19, 2014

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 4, 2013

LARGE MOD HEAD ADAPT 12/14 +5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·November 6, 2014

ADAPTA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 31, 2011

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2013

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025