Planmed Oy has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Planmed Verity Extremity Scanner for providing fast 3D imaging of subtle extremity fractures that have been missed when using 2D radiographs at ...
US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The implant device, which exhibits ...
Tags: Modern Plastics, Evonik, VESTAKEEP PEEK, FDA
The US Food and Drug Administration (FDA) has granted 510(k) approval to Zoll Medical's fully automatic version of ZOLL AED Plus. Using the company's proprietary feedback technology, Real CPR Help, the new fully automatic device provides ...
Tags: FDA, ZOLL AED Plus, Medical
The US Food and Drug Administration (FDA) has granted 510(k) approval to Ethicon Endo-Surgery's ENSEAL G2 Articulating Tissue Sealer, designed to allow surgeons to take a perpendicular approach to seal vessels up to 7mm in diameter and ...
EnteroMedics has reported ReCharge study results of its VBLOC vagal blocking therapy, designed for the treatment of obesity. The pacemaker-like Maestro system delivers VBLOC therapy via two small electrodes that are laparoscopically ...
The US Food and Drug Administration (FDA) has approved Elite Pharmaceuticals' supplemental application for naltrexone hydrochloride 50 mg tablets. Naltrexone, an opioid receptor antagonist, is used primarily to manage alcohol dependence ...
Tags: FDA, Pharmaceuticals, naltrexone tablets
US-based Smiths Medical has gained US marketing rights for its CADD-Solis variable infusion profile (VIP) ambulatory infusion system, following the US Food and Drug Administration (FDA) approval. The multi-therapy infusion system, which ...
Tags: FDA, therapy infusion system, Medical
The US Food and Drug Administration (FDA) has unveiled the Nutrition Facts Label tool, which can be found on all packaged foods and beverages. The Nutrition Facts Label helps to track various nutrients that are available from the foods ...
Tags: FDA, New Labeling Tool, Nutrition Facts Label, Packaging
The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml. Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is ...
Tags: FDA, Sun Pharma, Pharmaceutical
Kips Bay Medical has treated the first US patient in a multi-center, randomized eMESH I clinical trial using its extravascular nitinol (nickel titanium alloy) prosthesis. The prosthesis, eSVS Mesh, is used as an external saphenous vein ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stanmore Implants' Sculptor Robotic Guidance Arm (RGA) for unicompartmental knee replacement surgery, also known as partial knee resurfacing. Partial knee ...
Tags: FDA, surgical, orthopaedic market
US-based Domega NY International is recalling Green Day Brand Dried Coconut as it contains undeclared sulfites, according to the US Food and Drug Administration. The product being recalled bears UPC code 6 950296 800744 and carries expiry ...
Tags: dried coconut, Food, Agriculture
Sprouters Northwest is voluntarily recalling all varieties of its sprouts products as they are found to be contaminated with Listeria monocytogenes, according to the US Food & Drug Administration (FDA). The products subject to recall ...
Tags: Sprouters Northwest, sprouts products, FDA
The US Food and Drug Administration (FDA) has issued a final rule that strengthens its authority to detain potentially unsafe food from entering into the markets. The final rule makes the criteria for administrative detention in line with ...
St Jude Medical has treated the first patient with 25 mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing non-randomized, multi-center European trial. Made of bovine pericardial tissue, the 25 ...
Tags: Portico aortic heart valve, Medical, minimally invasive device