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Hemostatic - Articles

Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin: Class I Recall - Potent by FDA Posted Fri 14 Dec 2012 9:05am [Posted 12/14/2012] AUDIENCE: Risk Manager, Surgery ISSUE: There is an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. These products were manufactured from September 16, 2011 through July 27, 2012 and distributed from September 29, 2011 through August 7 ... Read on »
Class I Medical Device Recall: Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Th by Health & Human Services Posted Thu 13 Dec 2012 12:00am Reason for Recall: There is an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. This product may cause serious adverse health consequences, including death. Read on »
Class I Medical Device Recall: Synthes Hemostatic Bone Putty by FDA Posted Tue 21 Aug 2012 12:00am Reason for Recall: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. Read on »
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism by FDA Posted Fri 09 Jul 2010 9:35am [Posted 07/09/2010] AUDIENCE: Surgery, Operating Room Nursing ISSUE: FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These adverse events appear to be related to use of spray devi ... Read on »
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices by FDA Posted Thu 08 Jul 2010 9:00pm Date Issued: July 9, 2010 Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room Products: Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressu ... Read on »
CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R) by Health: Hearsay & Headlines Posted Wed 04 Nov 2009 10:04pm /PRNewswire/ -- CryoLife, Inc., (NYSE:CRY) , an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix prot ... Read on »
CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R) by Health: Hearsay & Headlines Posted Tue 27 Oct 2009 11:03pm /PRNewswire/ -- CryoLife, Inc., (NYSE:CRY) , an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix protein ... Read on »
Sprayable Bandage by Dr. Erik McLaughlin Medical Doctor Posted Sat 13 Jun 2009 12:30am Many thanks to the crew over at www.Wilderness-Survival.net for the tip on this pretty interesting type of “bandage”. http://www.njbiomaterials.org/web/index.php?p=cembr&s=2288 is the link to a company that is making a spray-on-bandage. This has obvious applications in remote medical settings. After the large amount of use the rapid he ... Read on »
Quikclot evolution and personal experience by Bobcat66 Posted Mon 21 Sep 2009 7:18am Challenge Z-Medica, a medical research company specializing in hemostatic agents, had created a revolutionary blood-clotting product called QuikClot® brand hemostatic agent. The adsorbent granules come in a unique sponge format that can easily be applied directly onto a wound. When accompanied by direct pressure, QuikClot can stop bleeding with ... Read on »
PMA Final Decisions for June 2010 by FDA Posted Mon 02 Aug 2010 9:00pm Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a ... Read on »

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