Posts tagged medical devices

• FDA Reclassifies Mesh Devices

  Darren Tobin | January 10, 2012 10:28 AM | 0 CommentsAtlanta, GA Category: FDA & Prescription Drugs
  

  The FDA recently released an update on the surgical mesh implant devices based on an assessment of Medical Device Reports that were given to the FDA. The FDA is considering the recommendation...

• Metal on Metal Hip Implant Complaints Continue To Pour In

  Darren Tobin | September 09, 2011 10:42 AM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  Hip implant complaints are surging as more information is revealed about the dangers of metal on metal hip joint devices. Recent studies show that the FDA received more than 5,000 reports since...

• FDA Knew Problems Existed With Triad Products

  Darren Tobin | March 07, 2011 10:51 AM | 0 CommentsAtlanta, GA Category: Miscellaneous
  

  A key role that the FDA performs is gate-keeping defective, or worse, dangerous products from being dispensed to the general public. As part of this duty, the FDA will conduct inspections under the...

• Medtronic Recall given FDA’s most Serious Score

  Jessica Smagacz | June 14, 2009 2:59 PM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  This past Thursday, FDA said that thousands of Medtronic pacemakers may potentially cause serious injury or death, according to AP. The pacemakers may have wiring defects that can cause them to...

• STAR System Approved by FDA

  Jessica Smagacz | May 29, 2009 10:02 AM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  FDA recently approved a total ankle replacement system, the Scandinavian Total Ankle Replacement (STAR) system. STAR may preserve some range of motion in arthritic or deformed ankles, according to...

• FDA not enforcing medical device safety standards

  Jessica Smagacz | February 18, 2009 11:34 PM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  The Associated Press reported today that an independent watchdog group said FDA “has quietly scaled back enforcement of federal quality regulations at labs that develop medical...

• Some Medical Devices Approved without Scientific Review

  Jessica Smagacz | January 16, 2009 11:43 AM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  FDA has approved 228 medical devices without full scale reviews from the years 2003-2007 according to a report by the Government Accountability Office reports Fox News. This happened even though...

• FDA Recall of Ophthalmic Surgical Device

  Jessica Smagacz | January 05, 2009 12:07 PM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  FDA announced a recall on January 2 of UD 30654 of Healon D, an ophthalmic viscosurgical device (OVD). This device is manufactured by Advanced Medical Optics Inc. of Santa Ana, California. On...

• FDA Class 1 Recall: Stryker Cranial Implants

  Jessica Smagacz | December 31, 2008 10:47 AM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  Stryker Leibinger USA, a firm based in Portage, Michigan, is recalling it Stryker Custom Cranial Implant kits product. FDA reported this product as recalled on October 24, 2008. The products use:...

• Do you have PAGCL?

  Jessica Smagacz | November 08, 2008 4:44 PM | 0 CommentsAtlanta, GA Category: Medical Devices & Implants
  

  PAGCL stands for Postarthroscopic Glenhumeral Chondrolysis. PAGCL is a condition caused by the deterioration of cartilage around the shoulder area. Recent studies have suggested the use of pain...