12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005183·Pain Control Kit - Basic with Shipper Cap
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494000929·ambIT* Pain Control Kit - Basic with Shipper Cap
MST/Dewey .9mm A1 Phaco Tip 45deg
FDA UDI
MICROSURGICAL TECHNOLOGY, INC.·00844685000258·
8MP COLOR LCD MONITOR, REDIFORCE RX840
FDA 510(k)
FDA Class 2
·Radiology
COMFORT WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
PLYAXL OPN SCRWDRVR - MODULAR TI MOD
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code HXX·October 31, 2008
BARD
FDA Adverse Event
Injury
·BARD ACCESS SYSTEMS INC.·Product code LJT·August 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
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
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024