BEUDAMED
    75 results · 14ms · 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 ×

    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MBV·November 15, 2012

    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·March 20, 2013

    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·January 18, 2013

    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·February 18, 2015

    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 28, 2011

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018

    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·January 12, 2015

    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

    Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

    Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MBB·November 7, 2006

    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code MAV·April 12, 2017

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code MAV·August 25, 2016

    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

    FDA Recall
    Terminated ·Medtronic Vascular·Product code MAV·February 6, 2014

    Viceroy Inflation Syringe, 60mL, without gauge.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·October 21, 2005

    IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code MBB·September 16, 2013

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    FDA Recall
    Terminated ·PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France·Product code MAV·October 6, 2014