13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189350·AK3 Femoral Distal Locating Device, 6° Bushing
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103060·Shaver, Closed, 6mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024014·Paddle Shaver, 6mm
MEDCOMP EXCELL SPLIT TIP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PINNACLE ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 16, 2011
Rascal 600F and 600T scooters, unspecified power wheelchair.
FDA Recall
Terminated
·Electric Mobility Corp·Product code ITI·April 17, 2006
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011