83 results
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10ms
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Sources: EU EUDAMED, US FDA
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 4, 2012
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 31, 2012
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·September 2, 2015
Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
FDA Enforcement
Class II
·Terminated·Ethicon Endo-Surgery Inc·February 6, 2013
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·January 13, 2016
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 18, 2018
PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 18, 2018
PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PRONOVA SUTURE BLUE 122CM M1.5, D10189
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018