7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MTS Doxycycline 0.016 - 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
FDA 510(k)
FDA Class 2
·Radiology
TRIPLE LUMEN PFM PICC
FDA 510(k)
FDA Class 2
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 21, 2014
ROUND TIP SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013
TORNIER AEQUALIS REVERSED II
FDA Adverse Event
Malfunction
·TORNIER·Product code KWS·July 19, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014