13 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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MOTIFMESH SOFT TISSUE PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3D
FDA UDI
Rmo, Inc.·00885797100061·3D MX BIMETRIC DISTL ARCH ASST
CT LUCIA
FDA UDI
CARL ZEISS MEDITEC PRODUCTION, LLC·00843045100997·3-piece, monofocal, hydrophobic, acrylic, intra...
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·May 19, 2006
EUSURE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 21, 2017
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·August 14, 2006
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 10, 2013
SM104 MSERIES W5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 14, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·July 2, 2025
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012