BEUDAMED
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    TriMed Threaded Intramedullary Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iTero 5D Scanning Unit

    FDA UDI
    Align Technology, Inc.·00816063020868·Scanning unit

    BD Difco™ Salmonella O Antiserum Group N Factor 30

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902117834·BD Difco™ Salmonella O Antiserum Group N Factor 30

    Sugita AVM Microclips

    FDA 510(k)
    FDA Class 2 ·Neurology

    MULTI-SNARE SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·October 24, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021