17 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SLEEK OTW PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234066·Orthopaedic prosthesis instrument, reusable - G...
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234059·Orthopaedic prosthesis instrument, reusable - G...
MONO-SWIFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUSA EXCEL 23KHZ STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·December 22, 2015
MULTI-LINK VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·May 24, 2013
QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012