19 results · 26ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX

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

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484367·PYRAMESH TALL C IMPLANT CASE

PYRAMESH® Implant System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000176846·CASE 9050898 PYRAMESH TALL C IMPLANT

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013

ULTRACISION SURG, DEV, BLADES 5MM OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006

ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145

FDA 510(k)
FDA Unclassified ·Unknown

EEG WITH VIDEO, MODEL EX-NW

FDA 510(k)
FDA Class 2 ·Neurology

ZILVER 518 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

NIM-ECLIPSE® ELECTRODE

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016

NIM-ECLIPSE® ELECTRODE

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

ATTAIN OTW

FDA Adverse Event
Malfunction ·MPRI·Product code LWP·April 10, 2013

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

FDA Adverse Event
Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·April 12, 2011

DIGITAL PREAMPLIFIER

FDA Adverse Event
Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

CONTROLLER ECLC ECLIPSE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

ZILVER 518 SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

IPC® HANDPIECE - STYLUS TOUCH®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024