New medical device approvals: April - September 2012
Undefined
FDA continues to gather information on the circumstances surrounding the patient’s death.
This product may cause serious adverse health consequences, including death.
Product marketed as dietary supplement contains drug ingredient Sibutramine, and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Use of Omontys may result in serious hypersensitivity reactions including
anaphylaxis, which may be life-threatening or fatal.
Fracture of the sleeve at the taper joint may lead to loss of function or loss of limb, infection, compromised soft tissue or death.
Vistide (Cidofovir Injection) by Gilead: Recall - Presence of Visable Matter
Potential reversal of oxygen/air concentrations may cause serious adverse health consequences, including death.
Core wire fracture may lead to serious adverse health consequences, including death.
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