13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENUS Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613020552·Freer Septum Knife, D-Shaped Knife, Flat Handle...
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·18100013402064·SINGLE INSTRUMENT
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·10840200302064·SINGLE INSTRUMENT
FRESENIUS LIBERTY CYCLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
MICROFILL TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 6, 2006
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 23, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 3, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 15, 2018
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·July 31, 2017