BEUDAMED
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    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

    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

    FDA Recall
    Terminated ·Krishe Inc·Product code QBD·March 11, 2021

    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

    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

    FDA Recall
    Terminated ·Mercedes Medical, Inc.·Product code QBD·June 10, 2021

    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.

    FDA Recall
    Terminated ·BASE 10 GENETICS INC·Product code QBD·January 10, 2022

    Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE

    FDA Recall
    Terminated ·Krishe Inc·Product code QBD·March 11, 2021

    Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

    FDA Recall
    Terminated ·Mercedes Medical, Inc.·Product code QBD·June 10, 2021

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·November 1, 2017

    VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020