11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Manual Wheelchair (Model W28)
FDA 510(k)
FDA Class 1
·Physical Medicine
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742747·Hohmann Retractor 9-1/4" (23.1cm), blade 70mm wide
ACUMED
FDA UDI
Acumed LLC·10806378014383·3.5mm x 60.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014390·3.5mm x 60.0mm Locking Cortical Screw
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HEC 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COREGA CREAM
FDA Adverse Event
GLAXOSMITHKLINE·Product code KOL·October 1, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
ANI [ A&I ] GROUP TAIWAN·Product code IOR·July 1, 2013
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