10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
FDA 510(k)
FDA Class 2
·Anesthesiology
HERMETIC LUMBAR CATHETER, CLOSED TIP
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·May 15, 2017
XTRA AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
CANARY BREATHING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·July 14, 2011
LONG 45 ENDOCUTTER
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 16, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
XTRA AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code CAC·August 2, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012