BEUDAMED
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    Noris Medical Dental Implants System - Cortical

    FDA 510(k)
    FDA Class 2 ·Dental

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087236·SOLUTION SYSTEM FEMORAL GRAFT TAMP - OFFSET 19m...

    DOLPHIN 3 FLUID MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OSMED TISSUE EXPANDER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CANCELLOUS

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 29, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·August 12, 2011

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    Proclaim DRG Implantable Pulse Generator, Model Number 3664

    FDA Enforcement
    Class II ·Terminated·St. Jude Medical, Inc.·April 4, 2018

    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 L111, ESSENTIO DR SL MRI Pacemaker

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