BEUDAMED
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    Aesculap Slim Clip Applier

    FDA 510(k)
    FDA Class 2 ·Neurology

    iTero Element 5D Plus upgrade cart configuration

    FDA UDI
    Align Technology, Inc.·00816063020721·Scanner, upgrade cart configuration

    NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 17, 2017

    OMNIPOD 5 POD

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·June 1, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 3, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Death ·INSULET CORPORATION·Product code LZG·July 19, 2023

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 22, 2008

    MUSTANG BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·August 15, 2011

    SPACELABS MULTIGAS MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS MEDICAL INC.·Product code CBR·July 8, 2013

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·December 13, 2023

    OMNIPOD DASH, PODS 10-PACK

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 9, 2023

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 23, 2024

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 21, 2022

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·July 11, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·April 17, 2023

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025