BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.

    FDA Enforcement
    Class II ·Terminated·J T Posey Company·April 17, 2013

    Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·October 29, 2014

    Stamey Needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 21, 2017

    Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip. The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·April 20, 2016

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

    FDA Enforcement
    Class II ·Terminated·Parker Medical·July 27, 2016

    PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·October 31, 2018

    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·December 22, 2021

    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 5, 2017

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Enforcement
    Class II ·Terminated·Mizuho America, Inc.·December 4, 2013

    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·October 29, 2014

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020