139 results · 30ms · 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.

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

THREADED ROD

FDA UDI
Biomet Orthopedics, LLC·00887868005862·

Valkyrie Thoracic Fixation System

FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391422·Plate Holder

CLARREN HELMET

FDA 510(k)
FDA Class 2 ·Neurology

GUARDIAN LIMB SALVAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SSW CARBIDE CAD CAM

FDA UDI
Ss White Burs, Inc.·D690SSWWIE07303520012·CAD/CAM CARBIDE LAZER SHARP SSWWIE-073035-20-01...

TRANSTART STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·April 6, 2013

SM104 MSERIES W5TH WHL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

RIATA ST OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·December 13, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 24, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 17, 2023

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code GBO·October 11, 2021

ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 1, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 5, 2024

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·August 6, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·November 30, 2020