11 results · 27ms · Sources: EU EUDAMED, 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