BEUDAMED
    88 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 8, 2015

    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·January 3, 2024

    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·August 28, 2013

    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·November 13, 2013

    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·November 13, 2013

    Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·August 21, 2013

    Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 20, 2019

    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·November 26, 2014

    Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·July 24, 2013

    Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Thin-Flex Venous Cannula, Model Number:TF292902A

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·December 16, 2015

    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

    FDA Enforcement
    Class II ·Ongoing·Edwards Lifesciences, LLC·April 17, 2019

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 12, 2014

    Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

    FDA Enforcement
    Class II ·Terminated·SPS Sterilization, Inc·September 19, 2018

    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·July 18, 2012

    Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 24, 2013