BEUDAMED
    36 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 Status: Terminated ×

    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc (AMO)·December 17, 2014

    AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size

    FDA Recall
    Terminated ·Advanced Medical Optics, Inc.·Product code LZP·October 29, 2008

    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)

    FDA Recall
    Terminated ·Abbott Medical Optics Inc (AMO)·Product code LZP·November 6, 2014

    Healon 5 Pro, Part No. 10270015

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Healon Pro, Part No. 10270012

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Healon V, Part No. 10290045

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017

    Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code LZP·October 4, 2010

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .

    FDA Enforcement
    Class II ·Terminated·Materialise USA LLC·January 1, 2014

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

    FDA Enforcement
    Class II ·Terminated·Materialise USA LLC·January 1, 2014

    Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code LZP·December 3, 2019

    J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.

    FDA Recall
    Terminated ·Ethicon, Inc US·Product code GCY·August 31, 2005

    Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.

    FDA Enforcement
    Class I ·Terminated·Bausch and Lomb, Incorporated·January 23, 2013

    Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.

    FDA Recall
    Terminated ·Bausch and Lomb, Incorporated·Product code HMX·November 15, 2012

    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

    FDA Recall
    Terminated ·Arrow International Inc·Product code OBJ·June 1, 2017

    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM

    FDA Recall
    Terminated ·Arrow International Inc·Product code OBJ·April 11, 2018

    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·April 25, 2016

    Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·June 4, 2015