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Hemostatic Side Effects
Hemostatic Warnings and Recalls
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Ethicon, Inc., SURGIFLO
Matrix and SURGIFLO
Matrix Kit Plus FlexTip with Thrombin: Class I Recall - Potent
. This product may cause serious adverse health consequences, including death. BACKGROUND: SURGIFLO
... (ligature) or when other conventional methods are ineffective or impractical. SURGIFLO
Public Workshop ?
Medical Devices for Trauma Use, September 3-4, 2014
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: ?
... challenges and opportunities related to
Class I Medical Device Recall: Synthes
Reason for Recall: There is the potential for
Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Johnson & Johnson Acquire Omrix Biopharmaceuticals
and leading provider of suture, mesh,
and other products for a wide range of surgical procedures...-based
and convergent products for various surgical applications. ETHICON currently...
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
can be used to mix and apply
drug or biological products (products that help control bleeding from blood...) MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical) Vitagel
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
drug or biological products using air- or gas-pressurized sprayers. These adverse events appear... devices and non-fibrin
drug or biological products also includes information on recommended...
PMA Final Decisions for February 2011
2/4/11 Special Vitagel Surgical
Orthovita, Inc. Malvern, PA 19355... in a material test method. P050044/S017 2/25/11 Vitagel Surgical
PMA Final Decisions for March 2011
3/17/11 Real-Time Femoral Introducer Sheath and
Device (FISH), FISH-SP Device...
Ethicon Incorporated Somerville, NJ 08876 Alternate cycle...
Two-day Tissue Adhesives / Soft Tissue Workshop / Symposium, September 26-27, 2011
of Hematology, OBRR/CBER 9:40 am-10:10 p.m. The Use of
..., Medical Adhesives, Sealants &
, CryoLife, Inc. 11:00 a.m.- 11...
PMA Final Decisions for July 2011
closure of femoral artery access sites. The system is indicated for use in reducing time...
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