Latest 510(k) Device Clearances

Date range: 2018-06-07 to 2018-07-08


Clearances
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510(k) Number Device Name
K151721 FIJI SUN FLUORESCENT TANNING UNIT
K161085 Nitrile Patient Examination Powder Free Glove, Tex
K170826 Perfadex Plus
K170835 Electro Antiperspirant, Electro Antiperspirant Sen
K170886 HOMED Mesh Nebulizer
K171197 Zuga Dental Implant System
K171414 qEEG-Pro
K171422 Disposable Powder Free Nitrile Examination Glove,
K172011 LifeSignals WiPoint Biosensor_iOS Receiver_App Sys
K172121 Digital Thermometer
K172345 IU Implant System
K172346 sterEOS Workstation
K172457 Deltex Medical CardioQ-EDM , Deltex Medical Cardio
K172483 Kopac Sterile Needle
K172536 Atlas Percussion Adjusting Instrument
K172551 Trinity PLUS Acetabular Shell
K172556 TubeClear System
K172586 Vios Monitoring System Model 2050
K172694 Sterile Disposable Syringes
K172721 FOCAL ONE
K172725 VT Dressing Kits
K172770 AIROS 6 Sequential Compression Device
K172778 CheckMyHeart Plus
K172779 AIROS 8 Sequential Compression Device
K172783 Access hsTnl
K172787 Access hsTnl
K172788 MONET Anterior Cervical Interbody Fusion Cage Syst
K172800 Portex® Lancet Point Spinal Needles with NRFit con
K172821 Ti-one 101 TS Dental Implant System
K172823 Portex NRFit Epidural Needles