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