16 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTVEST AIRWAY CLEARANCE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EOS SMALL BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CUSTODIOL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·September 29, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·June 17, 2011
CENTRAL VENOUS CATHETER
FDA Adverse Event
Injury
·COOK, INC.·Product code FOZ·August 15, 2012
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·March 19, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015