What are the requirements for exporting medical devices from the United States?

Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... 8 days ago ... Laser endoscopy ophthalmic system receives FDA 510(k) clearance · Study: Home OCT impacts physician decision making · FDA does ... The mean IOP ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Oct 24, 2023 ... 510(k) clearance is the FDA's primary regulatory process. It is ... This means that the current state of the art is no longer guaranteed. Dec 30, 2024 ... SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as ... Jul 29, 2024 ... The FDA's action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ...