Archive for the 'Medical Devices' Category
FLAIR Endovascular Stent Graft
The FLAIR Endovascular Stent Graft is used to treat a stenosis, a narrowing or blockage, which has developed at the connection of a vein and an arteriovenous (A-V) access graft, known as the venous anastomosis. An A-V access graft acts as an artificial… (Approved: 7/23/2007)Original post by Jacki …
CryoCor Cryoablation
An ?ablation catheter? is a plastic tube used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to occur. The CryoCor Cryoablation System causes ablation by applying extreme cold at the tip of the catheter, destroying the… (Approved: 8/1/2007)Original post by Jacki Donal…
VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System
These devices include a refractive excimer laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye according to the treatment plan; an eyetracker that detects the position of the eye and… (Approved: 7/11/2007)Original post by Richard …
Binax Now® Malaria Test
The Binax Now® Malaria analysis is a rapid laboratory antigen pop quiz that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. that is the first FDA product cleared for detection and identification of… (Approved: 6/13/2007)Original post by …
GeneSearch™ BLN experiment Kit
The GeneSearch BLN analysis Kit is a qualitative in vitro diagnostic tryout for the rapid detection of metastases larger than 0.2 mm in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. (See explanation of sentinel lymph node… (Approved: 7/16/2007)Original post by P…
Cormet Hip Resurfacing System
The Cormet Hip Resurfacing System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The Cormet System is called a resurfacing prosthesis considering only the surface of the femoral head (ball)… (Approved: 7/3/2007)Original post by Patri…
Perlane® Injectable Gel
Perlane® is composed of obvious, viscous gel particles of hyaluronic acid that are implanted into facial tissue to supply volume in or just under the skin to smooth wrinkles and folds, particularly around the nose, mouth and under the edges of the… (Approved: 5/2/2007)Original post by Brian White
PRESTIGE® Cervical Disc System
The PRESTIGE® Cervical Disc System is a two-piece metal device that is attached to adjacent vertebral bodies (neck bones) with bone screws to replace a diseased cervical disc. (Approved: 7/16/2007)Original post by Brian White
INRange Remote Medication Management System
The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to… (Approved: 6/13/2007)Original post by Brian Whit…
NOVATION™ Ceramic Articulation Hip System
The NOVATION™ Ceramic Articulation Hip System is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased or damaged hip joint. (Approved: 7/5/2007)Original post by Brian White
STS-7 continual Glucose Monitoring System
The STS-7 continual Glucose Monitoring System is a glucose sensor for domestic use that reports glucose values every 5 minutes for up to 7 days before a new sensor must be inserted. These readings are used with fingerstick glucose measurements to detect… (Approved: 5/31/2007)Original post by Patri…













