DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY:Â Food and Drug Administration, HHS. ACTION:Â Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation…
Class I Medical Device Recall: Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel
Recall Class: Class I Date Recall Initiated: March 2, 2012 Product: Other-Sonic Generic Ultrasound Transmission Gel.Lots sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers. Lot numbers: 060111 080111 090111 100811 Use: Other-Sonic Generic Ultrasound Transmission Gel is a non-sterile gel used in ultrasound procedures to improve the transmission and receiving of…
MQSA Alternative Standard #21: Correction Period When Components of the Agfa CR Full Field Digital Mammography Imaging System Fail Quality Control Tests
This alternative requirement was approved and became effective on May 21, 2012. It has no time limit. It allows a 30 day period for corrective actions following the failure of specified quality control tests by the Agfa CR Full Field Digital Mammography imaging system. The specified tests are equivalent to quality control tests for screen-film…
June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
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FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel
Date Issued: May 30, 2012 Audience: Surgeons, Operating Room Supervisors, Perioperative Nurses, Hospital Administrators, Hospital Risk Managers, Occupational Health Safety Managers, Infection Preventionists, Surgeon Educators, Surgical Residents, Medical School Administrators/Faculty, and other Personnel Medical Specialties: General Surgery, Urology, Obstetrics/Gynecology, Orthopedics, Anesthesiology, Surgical Technology, and any specialty that includes surgery of the muscle or fascia Purpose:…
Teva’s Adderall 30 mg Tablets: Counterfeit Product
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Waiver and Acknowledgement letter posted for June 13, 2012 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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Update to the 2012 Small Business Qualification Guidance
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24 Hour Summary and Presentations posted from the May 24, 2012 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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V Maxx RX: Recall
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