14 results · 24ms · Sources: EU EUDAMED, US FDA

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Esperance Distal Access Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Unity Total Knee System

FDA UDI
CORIN LTD·05056139233104·Unity ASC Size 6 Tibial Template Trial

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001424·Symmetry® Curette, Spinal, Angled, Size 3, 8 in...

MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL

FDA 510(k)
FDA Class 2 ·Radiology

NeuroBlate System

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

INFINITY

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·May 27, 2024

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·February 24, 2025

INFINITY

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·March 2, 2025

SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

FDA Adverse Event
Malfunction ·SUPERDIMENSION INC.·Product code JAK·October 30, 2008

AC POWER MODULE

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 20, 2011

PCA ST EMPTY VIAL

FDA Adverse Event
Malfunction ·HOSPIRA INC., HOSPITAL PRODUCTS DIVISION·Product code MEA·July 12, 2013

INFINITY

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·September 27, 2024

CD HORIZON SOLERA 4.75

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·February 13, 2026

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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