16 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849202·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...
CEBOTOME
FDA UDI
Conmed Corporation·10845854009109·CEBOTOME METAL-CUTTING BUR, SIDE-CUTTING ROUND ...
MICROPLEX COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
FDA 510(k)
FDA Class 2
·Cardiovascular
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 29, 2023
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
PRG CYLIN VALVE ASD RICK
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·April 11, 2013
COBRA REVOLUTION
FDA Adverse Event
Malfunction
·ENDOSCOPIC TECHNOLOGIES INC, DBA ESTECH·Product code GEI·March 25, 2011
BV BLUE, GRYPHUS DIAGNOSTICS
FDA Adverse Event
Other
·Product code MXB·May 23, 2008
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016