BEUDAMED
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    SICtapered & SICvantage tapered

    FDA 510(k)
    FDA Class 2 ·Dental

    ACUFEX, DUCKBILL

    FDA UDI
    Smith & Nephew, Inc.·00885554012705·SOD DUCKBILL BSKT PNCH REV UPBITER

    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

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197127615·Key elevator 18cm, 3mm

    DYONICS VISION 111 MOBILE VIDEO UNIT

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

    SLIT LAMP SL-2G

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDLINE UNITE

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·October 29, 2014

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·August 12, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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