BEUDAMED
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    VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113706·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 S...

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100823·VBR,SPACER,12X14X23,0 DEG

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00817470009453·GUIDEWIRE AIMER

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586023781·

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376266251·4.0mm Variable Angle, Self Tapping Screw, Dual ...

    TruFit™

    FDA UDI
    Ortho Organizers, Inc.·00190707191931·TruFit 2.0 018 MC LL6/7 NC SBT -10T 0DOff DB SB...

    STARBAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    BABY TEETHER, MODEL 20104

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 23, 2008

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 17, 2011

    BASEPLATE IMPACTOR EXTRACTOR

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·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