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Summary Information for: TRIDYNE™ Vascular Sealant
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Summary Information for: Vysis CLL FISH Probe Kit
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Olanzapine: Drug Safety Communication
Including Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax [Posted 05/10/2016] AUDIENCE: Psychiatry, Dermatology, Patient ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products…
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall
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FDA-Industry MDUFA IV Reauthorization Meeting, April 6-7, 2016
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Technical Considerations for Additive Manufactured Devices
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Waiver and Acknowledgment Letter posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting
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Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall
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Beacon Tip Technology Catheters by Cook Medical: Recall
[Posted 05/04/2016] AUDIENCE: Risk Manager ISSUE: On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date….