<!– –> <!– Page Last Updated: 05/06/2011 –> Page Last Updated: 05/06/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Consumer Information on: cobas HPV Test
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: cobas HPV TestPMA Applicant: Roche…
Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy
<!– –> <!– Page Last Updated: 05/06/2011 –> Page Last Updated: 05/06/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy
Date Issued:Â May 5, 2011 Audience: Urologists, Transplant Surgeons, Kidney Transplant Physicians, Hospital Administrators, Hospital Risk Managers, Clinical Transplant Coordinators, Operating Room Supervisors and Staff, and Patients Medical Specialty: Kidney Donor Transplant Surgery, (Tertiary) Surgery Care, Hospital and Other Medical Center Kidney Programs Purpose: The Food and Drug Administration (FDA) and the Health Resources and…
April 2011 510(k) Clearances
<!– –> <!– Page Last Updated: 05/03/2011 –> Page Last Updated: 05/03/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products
On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency’s recommendations for improving dosage delivery devices, such as cups and droppers, for over-the-counter (OTC) (i.e., non-prescription) orally ingested liquid drug products. The intent of this guidance is to suggest ways manufacturers can improve their labeling…
Boston Scientific Devices Stolen – Risk of Infection
<!– –> <!– Page Last Updated: 05/04/2011 –> Page Last Updated: 05/04/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
MQSA National Statistics
<!– –> <!– Page Last Updated: 05/03/2011 –> Page Last Updated: 05/03/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Class I Medical Device Recall: bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP2) ? Expanded Recall
Recall Class: Class I Date Recall Initiated: March 10, 2011 Product: bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP) AST-N183, REF 411 021 AST-N184, REF 411 154 These products were manufactured and distributed from September, 2010 through April, 2011. The two products under the expanded recall were distributed in foreign countries only….
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall
<!– –> <!– Page Last Updated: 05/03/2011 –> Page Last Updated: 05/03/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.