62 results · 22ms · 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.

EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII

XIA STAINLESS STEEL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 17, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·October 7, 2020

LIGASURE

FDA Adverse Event
Injury ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·July 21, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 20, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 26, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 9, 2021

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 2, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 13, 2018

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 16, 2019

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 24, 2020

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 14, 2019

LIGASURE

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 16, 2021

TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

FDA Enforcement
Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 9, 2013