7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROPROTEIN STANDARD KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEST INDUSTRIES CARTRIDGE & GUN
FDA 510(k)
FDA Class 1
·Radiology
NOZOVENT, NASAL DILATOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
8 MM MCS TIP COVER ACCESSORY
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 15, 2014