35 results · 25ms · 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.

ARIX Foot System

FDA 510(k)
FDA Class 2 ·Orthopedic

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA 510(k)
FDA Class 2 ·Orthopedic

DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560

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

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929066256·Corpectomy, 16Dx18Wx64H 0°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929066560·Corpectomy, 16Dx18Wx64H 6°

KYPHOPAK TRAY

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·May 24, 2021

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·November 6, 2019

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·April 5, 2021

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·July 11, 2019

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·August 31, 2019

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·March 7, 2018

VALIANT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 10, 2014

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

ENDURANT STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 8, 2011

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·May 17, 2018

1030489-2019-01511

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

KYPHON XPANDER

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·March 23, 2021

KYPHON XPANDER¿ II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code HRX·August 26, 2025

KYPHON XPANDER

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·April 15, 2019

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code HRX·May 29, 2019