FDA releases July 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016 TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16 DEVICE: Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional) ATTN: Stephen Deardorff PHONE NO : 1 317 8494210 10377 HAGUE RD. SE DECISION MADE: 21-JUL-16 INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheath Introducer BIOTEQUE CORP. 510(k) NO: K150932(Traditional) ATTN: Simon Lin PHONE NO : 886 2 25710269 5 F-6, NO. 23, SEC. 1 CHANG-AN E. SE DECISION MADE: 22-JUL-16 TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Compan510(k) NO: K151424(Traditional) ATTN: Scott Keiser PHONE NO : 561 4404460 801 US Highway 1, Suite B SE DECISION MADE: 27-JUL-16 North Palm Beach FL 33408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET III Bio-SA Fixture System HiOSSEN Inc. 510(k) NO: K151626(Traditional) ATTN: David Kim PHONE NO : 267 759 7031 85 Ben Fairless Dr. SE DECISION MADE: 21-JUL-16 Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT Platinum Depthalon Depth Electrode PMT CORPORATION 510(k) NO: K151790(Traditional) ATTN: KIM SCHMELZER PHONE NO : 1 952 4700866 1500 PARK RD SE DECISION...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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This study revealed the association between PAH exposure and markers of inflammation and oxidative stress, and the enhanced responses of pre-T2D patients suggested that individuals with metabolic disorders were more susceptible to the adverse health effects of PAH exposure. PMID: 32464779 [PubMed - in process]
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
In this study, five machine learning algorithms and twelve types of molecular fingerprints were employed to generate QSAR discriminant models for mitochondrial toxicity. A threshold moving method was adopted to resolve the imbalance issue in the training data. Consensus of the models by an averaging probability strategy improved prediction performance. The best model has correct classification rates of 81.8% and 88.3% in ten-fold cross validation and external validation, respectively. Substructures such as phenol, carboxylic acid, nitro and arylchloride were found informative through analysis of information gain and freque...
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
In this study, mushroom residue was adding in lead-zinc slag to enhance the phytoremediation potential of P. fortunei, the effects of three treatments (lead-zinc slag, red soil, lead-zinc slag + 10% (m/m) mushroom residue) on the growth, physiology and microstructure of P. fortunei were determined. The results showed that the addition of mushroom residue increased the biomass, plant height and chlorophyll concentration of P. fortunei, indicating that the addition of mushroom residue can facilitate the growth of P. fortunei. Moreover, the proportions of oxalate-Pb forms and phosphate-Zn were do...
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
Abstract Zeranol is an approved but controversial growth-promoting agent for livestock in North America. It is a mycotoxin metabolite secreted by the Fusarium family fungi. The regulatory bodies in this region have established the acceptable daily intake and exposure below the level would not significantly increase the health risk for humans. However, their European counterparts have yet to establish an acceptable level and do not permit the use of this agent in farm animals. Given the growth-promoting ability of zeranol, its effect on energy metabolism was investigated in the current study. Our results indicated ...
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
This study examined the feasibility and effects of a 1-hr physical activity (PA) behavior change (PABC) discussion session on PA, 12 weeks after completing an exercise trial. Adults at high risk of Type II diabetes were randomized to the PABC or a control group. PA was self-reported using the International Physical Activity Questionnaire. Chi-square tests compared the proportion of participants classified as moderately active or greater at the 12-week follow-up. Participants (N = 50) were M = 61.8 ± 5.5 years old and mostly female (80%). All participants completed the PABC discussion session, and compliance wit...
Source: Journal of Aging and Physical Activity - Category: Geriatrics Tags: J Aging Phys Act Source Type: research
Publication date: Available online 29 May 2020Source: Pregnancy HypertensionAuthor(s): Mamoru Morikawa, Michinori Mayama, Yoshihiro Saito, Kinuko Nakagawa, Takeshi Umazume, Kentaro Chiba, Satoshi Kawaguchi, Kazutoshi Cho, Hidemichi Watari
Source: Pregnancy Hypertension: An International Journal of Womens Cardiovascular Health - Category: OBGYN Source Type: research
Publication date: Available online 29 May 2020Source: Pregnancy HypertensionAuthor(s): Adebamike A. Oshunbade, Arsalan Hamid, Seth T. Lirette, Semiu O. Gbadamosi, Wondwosen K. Yimer, Olusola A. Orimoloye, Donald Clark, Daisuke Kamimura, Stephen D. Grado, Elizabeth A. Lutz, Robert J. Mentz, Ervin R. Fox, Javed Butler, B. Gwen Windham, Kenneth R. Butler, Thomas H. Mosley, Michael E. Hall
Source: Pregnancy Hypertension: An International Journal of Womens Cardiovascular Health - Category: OBGYN Source Type: research
Publication date: Available online 29 May 2020Source: Pregnancy HypertensionAuthor(s): Sunitha Suresh, Ariel Mueller, Saira Salahuddin, Heba Naseem, Rohin Dhir, Sarosh Rana
Source: Pregnancy Hypertension: An International Journal of Womens Cardiovascular Health - Category: OBGYN Source Type: research
Conclusions In primiparous women 1-year postpartum, we found no associations between PFM force and measures of strength and fitness. This study’s results are consistent with existing literature that specific, targeted, and consistent pelvic floor exercises are the best way to improve PFM strength.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: Original Articles Source Type: research
This study aimed to investigate how a unilateral high-grade tear caused overdistension of LAM and whether tear positions affect the degree of distension. Methods A total of 209 women were screened by translabial ultrasonography. Then, 18 nulliparous women with an intact LAM and 26 postpartum women with unilateral levator ani defects were recruited. The anteroposterior diameter (AP), coronal diameter (LR), and hiatal area (HA) of the minimum levator hiatus were recorded and compared for assessing the distensibility. All 44 subjects underwent magnetic resonance imaging for the diagnosis of levator ani defect and detection...
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: Original Articles Source Type: research
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