15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Steripath Micro Blood Collection System
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869690973·MOSS PSO Compression Forceps with pawl
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68120066100000·Standard Poly Driver
BD¿ SYRINGE TIP CAP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code KYW·January 10, 2019
UNITY IS PATIENT VIEWER
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 17, 2008
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·August 11, 2011
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013
CAPSUREEPI
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVN·November 2, 2016
BAERVELDT SHUNT
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·September 10, 2020
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code MND·March 26, 2007
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code MND·March 26, 2007
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code GDO·April 4, 2007
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