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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Is it time to bring circulating tumor cell assays to the forefront of breast cancer surveillance?Journal of the National Cancer Institute
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Conclusion: Our meta-analysis suggests that the prevalence of IDH is lower than 12% for both the EBPG and the Nadir #x3c;90 definition which is much lower than stated in most reviews.Am J Nephrol 2019;49:497 –506
Source: American Journal of Nephrology - Category: Neurology Source Type: research
Conclusions: The surgical procedure for axillary lymph node dissection should be considered to avoid prolonged fluid discharge, and the lymph vessels should be ligated in axillary lymph node dissection. An ultrasonic dissector was not effective in reducing the total fluid discharge volume. An optimal axillary lymph node dissection technique should be developed. For the patients without drainage, careful postoperative treatment should be given to avoid infectious seroma formation, even for patients who underwent total mastectomy with sentinel lymph node retrieval. PMID: 31114633 [PubMed]
Source: Patient Safety in Surgery - Category: Surgery Authors: Tags: Patient Saf Surg Source Type: research
Authors: Gameiro J, Ibeas J Abstract Vascular access dysfunction is one of the most important causes of morbidity and mortality in haemodialysis patients, contributing to up to one third of hospitalisations and accounting for a significant amount of the health care costs of these patients. In the past decades, significant scientific advances in understanding mechanisms of arteriovenous fistula maturation and failure have contributed to an increase in the amount of research into techniques for creation and strategies for arteriovenous fistula dysfunction prevention and treatment, in order to improve patient care and...
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Objective: We reviewed medical records and conducted a nationwide survey to characterize the clinical features and determine the prevalence of biliary tract disease in girls and women with Rett syndrome (RTT). Methods: Sixty-two individuals with RTT and biliary tract disease were identified from the membership of Rett Syndrome Organization and patient files of the principal investigator. Medical records of 46 individuals were reviewed for presenting features, diagnostic tests, and treatment outcomes of biliary tract disease. We designed a questionnaire that probed the frequency of risk factors and treatment outcomes o...
Source: Journal of Pediatric Gastroenterology and Nutrition - Category: Gastroenterology Tags: Original Articles: Hepatology Source Type: research
Conclusion: Prognosis in advanced stage CCA is still very poor. However, multimodal treatment in palliative patients significantly prolong survival.Digestion
Source: Digestion - Category: Gastroenterology Source Type: research
Background The role of perioperative systemic therapy (PST) in the management of localized pancreatic neuroendocrine neoplasms (PanNEN) is unclear. Objectives We aimed to evaluate the benefit of PST compared to surgical alone (SA) in patients with localized PanNEN. Method We selected patients with stage I-III PanNEN who underwent curative-intent surgical resection in National Cancer Database from 2006 to 2014. Patients who had both PST and surgical resection were matched with patients who received SA by propensity score at 1-to-1 ratio with nearest neighbor method. Results 4,892 patients were included in this study ...
Source: Neuroendocrinology - Category: Endocrinology Source Type: research
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA ® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample p ack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news
, SCA Pharmaceuticals LLC ( “SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news
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