Latest 510(k) Device Clearances

Date range: 2017-02-28 to 2017-03-31


Clearances
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510(k) Number Device Name
K152534 Medisign MM1000 BT Blood Glucose Monitoring System
K153538 Dextramer CMV Kit
K153600 Consult Station TS
K153688 Edi Catheter ENFit
K160067 RenovoCath
K160139 Luggie Chair
K160287 Rapid Barostat Bag (RBB) Pump and Catheter
K160345 Glass Ionomer Cement
K160581 K3PRO Konus Additional Abutments and Implants
K160641 Solitaire Platinum Revascularization Device, 6x40
K160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia Sy
K160721 Vado Steerable Sheath
K160815 Interstitial Needles
K161077 RnD TE and RnD SE
K161141 ENFit Enteral Pump Syringes PENTA ENFit, ENFit Ent
K161250 OC-FLEX Flexible IntraOral Cannula
K161257 MultiPulse HoPLUS
K161304 EndoPur Filter
K161318 Phantom Fukushima Neurological Holding Systems, Ph
K161416 Multi-unit Abutment Plus
K161428 PerfectSmooth
K161430 Myoject Luer Lock Needle Electrode
K161469 Plum 360 Infusion System with MedNet/ Smart Card
K161530 Bluetooth blood pressure monitor
K161547 Transem and EchoGen Embryo Transfer Catheters
K161554 ENDOFLATOR 40, ENDOFLATOR 50
K161598 NobelZygoma 0
K161633 REXLON, REXSIL
K161635 AMIStem-H Proximal Coating
K161655 On1 Concept