A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process.
The small area at the rear of the back hall, adjacent to the kitchen, was configured to include a small hand sink and built-in cabinet for instruments.
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A business incubator for medical device development in preparation for commercialization, AMI was founded in 1998 when billionaire medical device entrepreneur and philanthropist Alfred E. Mann made a $100 million gift to USC, a major private research university in Los Angeles.
The lithotrite was an early medical device, invented by Jean Civiale, which was used to perform transurethral lithotripsy, the first known minimally invasive surgery, to crush stones inside the bladder without having to open the abdomen (lithotomy).
Synthes Holding AG (formerly Synthes-Stratec) is a multinational medical device manufacturer based in Solothurn, Switzerland and West Chester, Pennsylvania, United States.
Under the act, the trade of certain agricultural commodities (defined and listed under section 102 of the Agricultural Trade Act of 1978) and medicine/medical devices (defined and listed under section 201 of the Federal Food, Drug, and Cosmetic Act) became permitted (www.bis.doc.gov).
Abductor wedge, medical device that separates the legs of a patient
In 1981 Reinhold Schmieding started a medical device company called Arthroscopy Excision Instruments Inc., which focused on an emerging procedure known as arthroscopic surgery.And the initial investment was $60,000 from Reinhold Schmieding's personal savings .
Long spine board, a medical device used for the immobilization and transportation of patients with suspected spinal injuries (aka backboard)
Prior to this role, he was the president and CEO of ResMed, a medical device company that focuses on sleep-related respiratory disorders.
The company’s FDA cleared CorPath® System is the first medical device that allows interventional cardiologists to manipulate guidewires and balloon/stents from an interventional cockpit.
It has been awarded the aerospace quality management standard AS9100 (6 January 2006) and SW-CMM Level 3 software certification (9 February 2006) and ISO 13485 for medical device design and development.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
The IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.
After earning her M.B.A. from the University of Texas in Texas, Greene moved to the Twin Cities, where she worked in marketing for Pillsbury and General Mills before shifting to the medical device industry, working for Guidant and St. Jude Medical.
MERCI Retriever, a medical device used for treating ischemic strokes
It was developed by OptiMedica, an ophthalmic medical device company located in Silicon Valley (Sunnyvale, CA).
In 2011, Rowa was integrated in the global medical device company CareFusion, San Diego.
Prior to his appointment to the Administration by President Obama, Dr. Ondra was a Professor of Neurological Surgery at Northwestern University, and he chaired the Medical Device and Technology Committee at Northwestern Memorial Hospital.
A violet ray was a medical device developed in the early 20th century based on the coil technology discovered by Nikola Tesla, who is stated to be Violet's favorite inventor.