Latest 510(k) Device Clearances

Date range: 2017-07-18 to 2017-08-18


Clearances
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510(k) Number Device Name
K152257 Fujifilm Duodenoscope Model ED-530XT
K152300 Glucommander
K160850 Nucleoss Tpure Implant System
K161225 Paonan Armstrong Posterior Spinal Fixation System
K161358 Medline ReNewal Reprocessed Stryker Neptune 2 Mani
K161527 Teco Creatinine Enzymatic Reagent Kit
K161679 s LDL-EX SEIKEN
K161845 Electronic Blood Pressure Monitor
K162219 CADD« Infusion Disposables Portfolio with NRFit co
K162312 Biodegradable Powder Free Nitrile Exam Gloves with
K162507 Arzzt 3.5 / 4.5 Small & Large Fragments System
K162510 Non-Sterile, Powder-Free, Nitrile Examination Glov
K162633 Custom Bars
K162729 Aintree Intubation Catheter, Arndt Airway Exchange
K162744 Everyway OTC EMS, Model EV-805
K162768 ECG multi leads and IP-SET trunk cable, Monobloc E
K162778 Portable Slit Lamp Microscope
K162816 SML-OSA2 Appliances
K162832 731 Series Ventilators
K162856 Bonart Dental Handpieces (ART), Disposable Prophy
K162858 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE
K162867 MagDen Dental Implant System
K162917 Allerhope Allergy Skin Tester
K162948 Styptin, Hemogin-L, Hemodettes, and GingiGEL Alumi
K162950 VITEK MS
K162951 TUBETECH IV Administration Set
K162977 ADVIA 2120i, ADVIA 2120
K162991 YELLOW 560 Fluorescence Module
K163005 TIGR Matrix Surgical Mesh
K163025 DORA Disposable A.V. Fistula Needle Sets