7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXCOMP AND META ETCHANT
FDA 510(k)
FDA Class 2
·Dental
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
FDA 510(k)
FDA Unclassified
·Unknown
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2014
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015