14 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131382·MUA AO WP1.5GH Str
LINK Instruments - Handles and adapters
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575210855·Orthopaedic prosthesis instrument, reusable - G...
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
DPL NUVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO HERMES O.R. CONTROL CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 26, 2013
TALENT STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 3, 2012
ASPHERE M SPEC 12/14 40 -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 26, 2013
COBAS INTEGRA 400 PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 1, 2014
APPOSE ULC 35 WIDE SKIN STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code GDT·May 13, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology