510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2016
TOTAL 510(k)s THIS PERIOD 239
TOTAL WITH SUMMARIES 224
TOTAL WITH STATEMENTS 15
DEVICE: Applanation Tonometer
SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional)
ATTN: Weida Zhan PHONE NO : 8621 542 60421
Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16
SHANGHAI CN 200237 510(k) STATEMENT
DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Sugentech, Inc. 510(k) NO: K142754(Traditional)
ATTN: Mijin Sohn PHONE NO : 82 42 3645001
Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-APR-16
Daejeon KR 305-811 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination gloves, Powderfree, Blue color
PRIMUS GLOVES PVT LIMITED 510(k) NO: K143477(Traditional)
ATTN: JOSE PAUL M PHONE NO : 91 484 2413063
PLOT No: 14-A, COCHIN SPECIAL ECONSE DECISION MADE: 14-APR-16
COCHIN IN 682037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUE METRIX GO Self Monitoring Blood Glucose System
Trividia Health, Inc. 510(k) NO: K143548(Traditional)
ATTN: Beth Foster PHONE NO : 1 954 6779201 3044
2400 NW 55TH COURT SE DECISION MADE: 01-APR-16
Fort Lauderdale FL 33309 510(k) STATEMENT
DEVICE: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
GLOBUS MEDICAL INC. 510(k) NO:…

Source: Mass DeviceCategory: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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ConclusionsPremolars restored with inlays fabricated using the tested methods had similar survival rates and loads to fracture.

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We report a case of a 39-year-old man with inferior vena cava (IVC) thrombus after withdrawal of IVC filter. He complained of 1-week history of swelling in his right leg, and computed tomography (CT) demonstrated occlusive thrombus in right femoral and popliteal veins. Venous thrombectomy was attempted after IVC filter placement. The filter was withdrawn without IVC filter-associated thrombus and the patient was discharged on warfarin. On day 21 after discharge, he complained of progressive swelling and CT revealed a significant amount of thrombus in IVC where the filter had been placed. Despite adequate anticoagulant ther…

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This study presents an opportunity to understand how multiple psychological traits and underlying molecular mechanisms interact to render individuals vulnerable to depression.





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