FDA releases February 2016 510(k) clearances

February 2016 510(k) Clearances 510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016. TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 213 TOTAL WITH STATEMENTS 11 February 2016 510(k) Clearances 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016 DEVICE: ANI Monitor MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional) ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081 6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16 LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBSWIN and VistaEasy Imaging Software Durr Dental AG 510(k) NO: K143290(Traditional) ATTN: Oliver Lange PHONE NO : 49 07142 7050 Hopfigheimer Strasse 17 SE DECISION MADE: 18-FEB-16 Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIARS SCREWS OVERMED SRL. 510(k) NO: K143596(Traditional) ATTN: DAVIDE PIZZAMIGLIO PHONE NO : 39 02 45712515 VIA LUCANIA 23 BUCCINASCO SE DECISION MADE: 05-FEB-16 MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AnapnoGuard 100 Respiratory Guard System HOSPITECH RESPIRATION LTD. 510(k) NO: K150157(Traditional) ATTN: Yoram Levy PHONE NO : 972 3 9191648 20 HAMAGSHIMIM ST. KIRYAT MATALON SE DECISION MADE: 16-FEB-16 PETACH TIKVA IL 49348 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pain Therapy System, Model PTS-II COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K150277(Traditional) ATTN: Eagle Eagle PHONE NO : 86 20 38289980 2ND &3RD FLOOR, BLD. 6, DAPIAN...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Jinsoo Lee, Seong-Jin Choi, Ji-Seong Jeong, Sang Yun Kim, Sang-Hyub Lee, Mi Jin Yang, Seung-Jin Lee, Young-Jun Shin, Kyuhong Lee, Eun Ju Jeong, Sang-Yoon Nam, Wook-Joon Yu
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
Publication date: Available online 30 September 2020Source: Journal of Hazardous MaterialsAuthor(s): Anthony Beauvois, Delphine Vantelon, Jacques Jestin, Martine Bouhnik-Le Coz, Charlotte Catrouillet, Valérie Briois, Thomas Bizien, Mélanie Davranche
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
We describe the most highly recommended generic and disease-specific PRO tools in SCD and discuss the challenges of incorporating them in clinical practice. EXPERT OPINION: PRO measures are essential to incorporate into SCD clinical trials either as primary or secondary outcomes. The use of PRO measures in SCD facilitates a patient-centered approach, which is likely to lead to improved outcomes. Significant challenges remain in adapting PRO tools to routine clinical use and in developing countries. PMID: 33034214 [PubMed - as supplied by publisher]
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
CONCLUSIONS: Immunohistochemistry seems to be a promising option not only in clinical recognition, but also in the selection and monitoring of treatment effects. However, these methods have not yet recommended for routine clinical use. PMID: 33032462 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Gastroenterology - Category: Gastroenterology Tags: Scand J Gastroenterol Source Type: research
Currently in fellowship doing bread/butter procedures (MBB, epidurals, PNB, few SCS/PNS trials, etc.) and just interviewed at a private practice spot where they do a lot of procedures that I will have not done any training in prior to graduating (e.g. IT pump, SI fusion, Vertiflex, Kypho, MILD, Discectomy, lots of SCS/PNS trials etc) and significant amount of "OR pain procedures" at a very busy practice seeing 30-40 pts/day - how many of you are commonly performing these procedures and are... private practice concern
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
Conclusions: This review results revealed a low utilization of postnatal care service. Antenatal care service utilization has a positive effect on postnatal care service utilization. Policymakers and programmers better considered more antenatal care service use as one strategy of enhancing the utilization of postnatal care service. PMID: 33029402 [PubMed - in process]
Source: Journal of Pregnancy - Category: OBGYN Tags: J Pregnancy Source Type: research
Authors: Debelew GT Abstract Despite several efforts globally, the problem of perinatal mortality remained an unsolved agenda. As a result, it continued to be an essential part of the third sustainable development goals to end preventable child deaths by 2030. With a rate of 33 per 1000 births, Ethiopia has the highest level of perinatal mortality in the world. Thus, determining the magnitude and identifying the determinants are very crucial for evidence-based interventions. A community-based longitudinal study was conducted in Southwest Ethiopia among 3474 pregnant women to estimate the magnitude of perinatal mort...
Source: Journal of Pregnancy - Category: OBGYN Tags: J Pregnancy Source Type: research
This study was aimed at assessing the magnitude of induced abortion and associated factors among students in Hawassa University, southern region, Ethiopia, 2019. Methods: An institutional-based cross-sectional study was conducted among a total of 422 students selected on the bases of a probability simple random sampling method. A pretested structured questionnaire was used to collect data. Analysis was made with SPSS 20. Descriptive summary and inferential statistics (binary logistic regression) were used with a 95% CI and P value of less than 5% as a level of significance. Findings were presented in tables, figure, an...
Source: Journal of Pregnancy - Category: OBGYN Tags: J Pregnancy Source Type: research
CONCLUSION: The proposed PHARMAC criteria will give access to these important drugs to those people with T2DM who will likely benefit the most. PMID: 33032305 [PubMed - in process]
Source: New Zealand Medical Journal - Category: General Medicine Tags: N Z Med J Source Type: research
Authors: Siamashvili M, Davis S Abstract INTRODUCTION: Bromocriptine mesylate quick release (QR) is a dopamine D2 receptor agonist and is the only oral, primarily centrally acting drug that can be used for the treatment of adults with type 2 diabetes. AREAS COVERED: The authors describe current recommendations on the use of bromocriptine mesylate QR. Major efficacy and safety parameters of the late phase trials, including The Cycloset Safety Trial, have been identified and presented. EXPERT OPINION: Efficacy of bromocriptine mesylate QR monotherapy appears to be low but is compensated by favorable safety pr...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
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