10 results
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29ms
·
Sources: EU EUDAMED, US FDA
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
STERIS CORPORATION·10724995152397·The Vis-U-All High Temperature Heat Seal Steril...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586N8831150·bone file #64, double-ended, plain serrations ,...
NA
FDA UDI
STRYKER CORPORATION·07613327064193·3.0 Fr., Nitinol Basket, Do not use if package ...
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
MTS Levofloxacin 0.002 - 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRACOSTA RICA LTD.·Product code FRN·May 23, 2014
ION NITRIDED BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code GFA·October 18, 2010
SARNS CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·December 18, 2012
Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018