BEUDAMED
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    Balteum™ Lumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CASTANARES SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055865·CASTANARES SCISSORS CURVED BLADES POWER CUT BLACK

    ULTIMA TENS XL-A1

    FDA 510(k)
    FDA Class 2 ·Neurology

    TKD SCALERS

    FDA 510(k)
    FDA Class 2 ·Dental

    Widex

    FDA UDI
    Widex A/S·05706069735758·Widex BEYOND B-F2 (Tan silk S-110 ) Telecoil, R...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·September 15, 2008

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·October 24, 2008

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    ENTERRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 8, 2011

    LAG SCREW, TI GAMMA3 Ø10.5X95MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 2, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 2, 2017

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 22, 2017

    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