16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE VAULT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
iScreen™
FDA UDI
Instant Technologies, Inc.·00817405021734·iScreen DOA Multi-Panel(Urine) 25T
NA
FDA UDI
Alere San Diego, Inc.·10815845020918·
iScreen™
FDA UDI
Instant Technologies, Inc.·00817405022489·iScreen DOA Multi-Panel(Urine) 25T
reditest®
FDA UDI
REDWOOD TOXICOLOGY LABORATORY, INC.·10858904006461·PANEL 12 COC/AMP/M-AMP/THC/MTD/MDMA/ OPI/OXY/PP...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970799·
8MP COLOR LCD MONITOR, REDIFORCE RX840
FDA 510(k)
FDA Class 2
·Radiology
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
FDA 510(k)
FDA Class 2
·Anesthesiology
COTTON CANNULATOME
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code KNS·May 15, 2013
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 18, 2024
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 18, 2024
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017
Artis zee floor, Model Number 10094135
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018