15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034004792·ISOLA SPINE SYSTEM LAMINAR HOOK STARTER
Sportex
FDA UDI
Diversified Products, Inc.·00037741405016·
EndoAVF® Balloon Inflation Kit
FDA UDI
Merit Medical Systems, Inc.·00884450413838·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450142523·
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376633459·PSIS Pin, 125mm
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376688633·PSIS PIN, STERILE 125mm
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
JET PORT PLUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 10, 2013
ACTIVA PC
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·April 1, 2011
EYEONICS-CRYSTAL LENS
FDA Adverse Event
Other
·Product code HQL·May 20, 2008
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
FDA Recall
Terminated
·Product code FTR·September 12, 2003
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·March 19, 2014
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003