11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Velano ExT Extension Set
FDA 510(k)
FDA Class 2
·General Hospital
Intraoral Scan Body NP 3.5
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075199·
STATUS HCG SERUM/URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C
FDA 510(k)
FDA Class 2
·Ophthalmic
PUMP MMT-1715KM 630G 3ML BLACK MEDI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·April 11, 2019
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 24, 2014
COULTER® ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 1, 2013
PRECISE SDS SELF EXPANDING
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·June 30, 2014
PRECISE SDS SELF EXPANDING
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·June 30, 2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014