BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    9x15" Medium Utility Positioner with Cover

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017

    7x10" Small Utility Positioner with Cover

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017

    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code FTL·December 17, 2014

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Acumed LLC·Product code LXH·February 17, 2017

    Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code MFC·June 22, 2009

    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    FDA Recall
    Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code FTM·December 29, 2021

    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

    FDA Recall
    Terminated ·Product code DQY·April 9, 2014

    Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

    FDA Recall
    Terminated ·Guidant Endovascular Solutions, Inc.·Product code FGE·August 8, 2005

    Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts

    FDA Recall
    Terminated ·Arrow International Inc·Product code DXE·February 11, 2009

    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

    FDA Recall
    Terminated ·ev3, Inc.·Product code LIT·March 29, 2016

    ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

    FDA Recall
    Terminated ·Medtronic Inc·Product code LIT·November 10, 2016

    MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

    FDA Recall
    Terminated ·Guidant Corporation ACS·Product code MAF·May 7, 2003

    Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code DQY·April 25, 2017

    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.

    FDA Recall
    Terminated ·Fujirebio Diagnostics, Inc.·Product code OAW·July 29, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.

    FDA Recall
    Terminated ·Cordis Corporation·Product code LOX·January 31, 2011