21 results · 22ms · Sources: EU EUDAMED, US FDA

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InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0106120·Trial, 26 x 12mm, 8 Degree, Tapered, Straight

VECTORVISION KNEE

FDA 510(k)
FDA Class 2 ·Neurology

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890106120·Zirlux Titanium Abutment 3 mmH compatible with:...

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317302342·

SIGHT STATION

FDA UDI
FGX INTERNATIONAL INC.·00193033213841·

SIGHT STATION

FDA UDI
FGX INTERNATIONAL INC.·00193033213797·

SIGHT STATION

FDA UDI
FGX INTERNATIONAL INC.·00193033213834·

SIGHT STATION

FDA UDI
FGX INTERNATIONAL INC.·00193033213810·

SIGHT STATION

FDA UDI
FGX INTERNATIONAL INC.·00193033213827·

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset

PASCO MIC AND MIC/ID PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·March 1, 2011

RIATA ST OPTIM PASSIVE-FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

ONYX AVM

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 4, 2022

MARATHON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·August 4, 2022

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code OUT·May 11, 2015

Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014