The searchable database contains the last 10 years of medical device report (MDR) data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
Download File: https://www.google.com/url?q=https%3A%2F%2Ftlniurl.com%2F2tLEYh&sa=D&sntz=1&usg=AOvVaw3b_SclCSwveSI-zm90iQaM
Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.
For distributor reports which have had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.
A manufacturer is a person or company that produces finished goods from raw materials by using various tools, equipment, and processes, and then sells the goods to consumers, wholesalers, distributors, retailers, or to other manufacturers for the production of more complex goods.
Manufacturers are considered a significant part of the economy. Manufacturing can be traced back to the ancient world. However, for many centuries, the typical manufacturer was a single skilled artisan with assistants. Each artisan kept the secrets of the production and transferred the knowledge only to apprentices. Production was limited to manual operations.
The Industrial Revolution was a pivotal point for manufacturers. One of the results of the Industrial Revolution was the introduction of new technologies (e.g., steam engines) that enabled the mechanization of production, which increased the volume of the goods produced. As a result, by the beginning of the 20th century, manufacturers were turning to mass production to make goods.
Nowadays, manufacturing is a quintessential component of a prosperous economy. Generally, modern manufacturers are associated with mass production. Technological advancements enable the mechanization of production processes, as well as improve overall efficiency and productivity.
Made to Stock manufacturers produce substantial quantities of goods and store the manufactured goods before their final sale. MTS businesses aim to forecast the demand for their products in the market and then produce the quantity of goods corresponding with the predicted demand.
The success of made to stock manufacturers mostly depends on their ability to forecast the market demand correctly. If the forecast significantly deviates from the actual demand, they will face the under- or over-production.
Unlike their MTS counterparts, made to order manufacturers produce goods only if they receive orders from customers. The nature of MTO production eliminates the necessity to forecast future demand for the products. Thus, MTO businesses will not face overproduction.
However, MTO manufacturers generally face a higher lead time between the initiation and completion of an order. In addition, a sudden increase in the current demand for the products tends to put additional pressure on the operations, which, in turn, will lead to even higher lead times.
Instead of immediately producing a final good, made to assemble manufacturers initially create the basic parts of a final good that can be quickly assembled together when an order from a customer is received. MTA production significantly reduces lead times for customer orders. Nevertheless, the business could face lower demand for certain types of basic parts.
Initial Importer - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
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The Florida Department of Highway Safety and Motor Vehicles (FLHSMV) Bureau of Dealer Services issues and renews licenses for more than 15,0000 motor vehicle, auction, salvage, wholesale, mobile home, recreational vehicle dealers and manufacturers, distributors and importers each year. The bureau also licenses mobile home installers and monitors the construction and installation of mobile homes.
A manufacturer, importer or distributor license is required to conduct business for the distribution and sale of motor vehicles, recreational vehicles or mobile homes in the state of Florida. Applicants must meet FLHSMV licensing requirements.
Confidentiality requirements generally restrict CPSC from publishing lists of product reports received from manufacturers, importers, distributors, or retailers, or from disclosing matters in active investigation.
Section 37 of the CPSA requires manufacturers of consumer products to report information about settled or adjudicated lawsuits. Under Section 6(e) of the CPSA , the Commission and its employees may not publicly disclose information reported under Section 37 of the CPSA, except that such information may be furnished to the reporting manufacturer or Congress, under certain circumstances. By law, reporting under Section 37 is not an admission of the existence of an unreasonable risk of injury, a defect, a substantial product hazard, an imminent hazard, or any other liability under any statute or common law. Information provided voluntarily that is in addition to information required to be reported under Section 37, is governed by the confidentiality provisions of Section 15 reports.
The OSHA regulation 29 CFR 1910.1200, the Hazard Communication Standard (HCS 2012), deals with hazardous chemicals in the workplace and covers Safety Data Sheets, workplace labeling, training, and more. The standard has specific definitions for chemical manufacturers, distributors, and importers:
Under paragraph (d) of HCS 2012, chemical manufacturers and importers are required to perform a hazard classification on substances which they produce or import and convey these findings on the product label and Safety Data Sheet:
Like all employers, any manufacturer, distributor or importer must provide information to their employees about the hazardous chemicals to which they are exposed in their workplaces by means of a written hazard communication program. The program includes labels and other forms of warning, safety data sheets, safety practices, and training.
Per 29 CFR 1910.1200, the OSHA Hazard Communication Standard, distributors and manufacturers are also required to transmit SDS and labeling information to their customers who are employers. This is called a \"downstream flow\" of information that assures that each subsequent employer who receives the hazardous material is apprised of the hazards.
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