9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156050·K-WIRE - SINGLE TROCAR 1.1mm DIA x 230mm
PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
FDA 510(k)
FDA Class 2
·General Hospital
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
LIBERTY CYCLER
FDA Adverse Event
Other
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 17, 2012
ALAIR BRONCHIAL THERMOPLASTY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·February 4, 2013
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·December 23, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·July 17, 2014
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016