25 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524025545·OPERATING SCI 6.5"" S/S CVD
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400498·
HAMILTON-C2
FDA 510(k)
FDA Class 2
·Anesthesiology
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 24, 2013
CLICKFINE 32GX4MM DONGBAO 7CT
FDA Adverse Event
Malfunction
·YPSOMED AG·Product code FMI·September 7, 2023
MCGRATH
FDA Adverse Event
Injury
·AIRCRAFT MEDICAL LIMITED·Product code CCW·October 11, 2019
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·January 7, 2022
LEAD MODEL UNKNOWN
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 14, 2009
LEAD MODEL UNKNOWN
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 13, 2009
2124215-2016-00634
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NIK·January 17, 2016
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·November 4, 2008
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 24, 2011
INTERSTIM
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code EZW·July 11, 2013
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·March 16, 2023
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 16, 2023
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016