FDA releases April 2016 510(k) clearances

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 Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Source: American Journal of Otolaryngology - Category: Endocrinology Source Type: research
Conclusion. A combination of chemotherapy and MSC can yield to more favorable results in the treatment of HCC. PMID: 32617114 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Zhan LH, Dong YJ, Yang K, Lei SS, Li B, Teng X, Zhou C, Luo R, Yu QX, Jin HY, Lv GY, Chen SH Abstract Suanzaoren decoction (SZRT), a classic Chinese herbal prescription, has been used as a treatment for insomnia for more than a thousand years. However, recent studies have found no significant effects of SZRT as a treatment for insomnia caused by gastric discomfort. Herein, we studied the effects of modified Suanzaoren decoction (MSZRD) on gastrointestinal disorder-related insomnia. The main constituents of MSZRD were spinosin (2.21 mg/g) and 6-feruloylspinosin (0.78 mg/g). A pentobarbital-ind...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Isolation of Oxyberberine and β-Sitosterol from Berberis lycium Royle Root Bark Extract and In Vitro Cytotoxicity against Liver and Lung Cancer Cell Lines. Evid Based Complement Alternat Med. 2020;2020:2596082 Authors: Anwar MA, Tabassam S, Gulfraz M, Sheeraz Ahmad M, Raja GK, Arshad M Abstract Berberis lycium Royle has been traditionally used to cure rheumatism, eye and ear diseases, malarial fever, diabetes, stomach disorders, and skin diseases. There is a least amount of data available on cytotoxic capacity of Berberis lycium from Pakistani origin, so on this basis, the present study was aimed ...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
CONCLUSIONS Sensory nerves and endothelial dysfunction contributed to the morphological damage of soft palate under intermittent hypoxia. Autophagy as a compensatory mechanism protects against CIH-induced injury. These findings have important implications for understanding mechanisms contributing to the increased soft palate lesion in patients with OSA. PMID: 32616707 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Publication date: Available online 3 July 2020Source: The Crop JournalAuthor(s): Zhitong Ren, Shaozhen He, Yuan-yuan Zhou, Ning Zhao, Tao Jiang, Hong Zhai, Qingchang Liu
Source: The Crop Journal - Category: Food Science Source Type: research
Conclusions: Preoperative higher ALFF in the bilateral MCC and lower FC between the bilateral MCC and left calcarine were independently associated with the occurrence of DNR. The present fMRI study identified possible preoperative neuroimaging risk factors for DNR. This trial is registered with Chinese Clinical Trial Registry ChiCTR-DCD-15006096. PMID: 32617099 [PubMed - in process]
Source: Neural Plasticity - Category: Neurology Authors: Tags: Neural Plast Source Type: research
Publication date: Available online 3 July 2020Source: Saudi Journal of Biological SciencesAuthor(s): Shafat Ali, Sabhiya Majid, Md. Niamat Ali, Shahnaz Taing, Hamed A. El-Serehy, Fahad A. Al-Misned
Source: Saudi Journal of Biological Sciences - Category: Biology Source Type: research
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Source: Journal of Trace Elements in Medicine and Biology - Category: Biochemistry Source Type: research
Publication date: Available online 4 July 2020Source: Comparative Biochemistry and Physiology Part A: Molecular &Integrative PhysiologyAuthor(s): Lea R. Medeiros, James J. Nagler, Andrew L. Pierce
Source: Comparative Biochemistry and Physiology Part A: Molecular and Integrative Physiology - Category: Biochemistry Source Type: research
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