BEUDAMED
    681 results · 19ms · 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 FDA Recall × Status: Terminated × Clear all

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code OQY·January 5, 2015

    Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.

    FDA Recall
    Terminated ·Butterfly Network, Inc.·Product code IYN·February 24, 2020

    Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit

    FDA Recall
    Terminated ·Taut, Inc.·Product code GBW·January 19, 2007

    Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

    FDA Recall
    Terminated ·Psi Health Solutions·Product code MVV·April 26, 2007

    Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

    FDA Recall
    Terminated ·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Ellex Super Q LQP3106 ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Cocoon Convective Warming System, Product Code: CWS5000 (110V).

    FDA Recall
    Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

    Alcon 3000LE ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Recall
    Terminated ·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020

    Ellex Tango LT5106-T ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Ellex Ultra Q LQP3106-U ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Revanesse Versa, PN40081

    FDA Recall
    Terminated ·Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada·Product code LMH·November 15, 2018

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    FDA Recall
    Terminated ·Southern Implants, (Pty.) Ltd. One Albert Road Irene, Gauteng South Africa·Product code NHA·March 8, 2018

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 10KPES SIZE: 10Fr Product No: AAM 8010KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 10KPES Product No: AAM 8010KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 8KPES Product No: AAM 8008KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011