BEUDAMED
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    Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDI·November 6, 2007

    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 Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GEI·November 6, 2012

    HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LFL·March 16, 2012

    ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDW·July 29, 2011

    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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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

    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 Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·July 10, 2015

    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015

    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·April 8, 2013

    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·January 16, 2019

    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·June 7, 2017

    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A

    FDA Enforcement
    Class I ·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019

    ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A

    FDA Enforcement
    Class I ·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019

    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·January 16, 2019

    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 23, 2018

    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A

    FDA Enforcement
    Class I ·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019