36 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.

U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

NITREX NITINOL GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA 510(k)
FDA Class 2 ·Orthopedic

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

AS INVERSE HUMERAL PE-INLAY 40-0

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSD·August 18, 2008

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

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code HRX·December 14, 2020

KYPHON XPANDER II INFLATABLE BONE TAMP

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·February 27, 2018