BEUDAMED
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    syngo.CT Extended Functionality

    FDA 510(k)
    FDA Class 2 ·Radiology

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100786·VBR,SPACER,12X14X19,0 DEG

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113669·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 X...

    Twin Tip Edge Sidewinder

    FDA UDI
    TP ORTHODONTICS INC·00192029028025·CCW Oriented

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376266213·4.0mm Variable Angle, Self Tapping Screw, Dual ...

    STEM EXTRACTOR

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·January 20, 2015

    NEUROTECH MEDISTIM PLUS, TYPE 291

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    LCS COMPLETE FEM POR L STD+

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MBH·October 27, 2008

    RAZOR2.5 WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORPORATION·Product code GEI·August 3, 2011

    REAMER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code HTO·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017