10 results
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18ms
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Sources: EU EUDAMED, US FDA
ON THE SPOT CANDIDASURE
FDA 510(k)
FDA Class 2
·Microbiology
NA
FDA UDI
STERIS CORPORATION·10724995152410·The Vis-U-All High Temperature Heat Seal Steril...
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331158551·bone file #10, double-ended, plain serrations, ...
URIC ACID REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code KNK·April 15, 2011
dpl SpotLite
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 18, 2012
UNK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 18, 2010
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 19, 2014
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 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