BEUDAMED
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    EzDent Web

    FDA 510(k)
    FDA Class 2 ·Radiology

    Misc Instruments and Sterilization Trays

    FDA UDI
    Smith & Nephew, Inc.·00885556827970·AO DRIVER HANDLE

    KMI Instruments

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280552·HANDLE AO COUPLE

    Tensoplast®

    FDA UDI
    BSN MEDICAL SAS·04042809005493·TENSOPLAST BANDAGE 3" X 5YDS WHITE 36

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327466836·LE FORT I PLATE, 0MM ADVANCEMENT, LEFT

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721312117000·

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702399707·ELVAREX 2/THIGH HIGH/CLOSED TOE-ELEPHANTIASIS-V...

    ULTHERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODULITH SLK LITHOTRIPTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 29, 2014

    P.F.C. FLUT TIB ROD 150X12MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 8, 2013

    Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·November 20, 2008

    Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·November 20, 2008

    Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021