ICU Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its ChemoLock needlefree closed system transfer device (CSTD). The CSTD is approved for pharmacy applications (product code ONB), as well as patient ...
Tags: ICU Medical, FDA Approval
StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system. ...
Tags: Stelkast, Total Knee System
Royal Philips Electronics has launched new Epiq premium ultrasound system designed to visualize deeper levels of anatomical detail and contrast resolution on patients of all types. Epiq, the new ultrasound system which features nSIGHT ...
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles. The two miniaturized versions of ...
Tags: Pediguard Products, SpineGuard
Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system. The system enables surgeons to plan the implant ...
Tags: Shoulder System, Surgical products
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes. Available to patients ...
Tags: Insulin Injection, Medicine
Clearance, an AngioDynamics company, has received the US Food and Drug Administration (FDA) 510(k) clearance for its BioFlo Port with Endexo technology, Clearance to the accumulation of platelets and thrombus. The BioFlo Port is a ...
Natus Neurology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Health Canada clearance for its new electrodiagnostic system, the UltraPro S100 EMG system. The UltraPro S100 is an EMG/nerve conduction ...
Verizon, a US- based broadband and telecommunications company, has received the US Food and Drug Administration (FDA) 510(k) clearance for a cloud-based, remote patient-monitoring medical device called Converged Health Management. ...
Tags: Verizon, Patient-Monitoring Device
Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer. It is used ...
Tags: FDA Clearance, HCG Fluorescent
Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. The Sofia Analyzer and ...
Tags: Quidel, Fluorescent Immunoassay
NEC Display Solutions, a provider of commercial LCD display and projector solutions, has received the Food and Drug Administration 510(k) clearance for its 21-inch MultiSync MD211G5 medical-grade monitor. The LED-backlit IPS diagnostic ...