BEUDAMED
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    VerSys Cemented Revision/Calcar

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087182·SOLUTION SYSTEM THINSHAFT REAMER 21.5mm DIA

    TruBase S

    FDA 510(k)
    FDA Class 2 ·Dental

    ATLAS SPINE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    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, CANCELLOUS

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

    MEDLINE UNITE

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

    I-STAT EC8+ CARTRIDGE

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

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 12, 2011

    SOFTCLIX ® PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 29, 2014

    FLEXTEND II

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

    SCREW, CORTICAL

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

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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 MRI S-ICD Model A219

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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015