10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTRA LARGE COMPRESS DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074087795·SHAVER 2940351 10MM
VARIAX
FDA UDI
Stryker GmbH·07613327177237·Small Fragment Tray Clip
ARROW GPSCATH BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX LIQUID CRP CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 26, 2014
BONE CEMENT
FDA Adverse Event
Injury
·KYPHON NEUCHATEL·Product code HRX·February 3, 2013
HEARTSTRING PROXIMAL SEAL SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·December 20, 2010
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020