BEUDAMED
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    MICROSCAN MICROSTEP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010607591·BONE CURETTE CURVED 45 DEG 228.6 ...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448609·

    CHLORAPREP ONE STEP HI LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·February 9, 2022

    LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM

    FDA 510(k)
    FDA Class 2 ·Dental

    ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 17, 2025

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 2, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    ARTICUL/EZE BALL 28 +15.5 WH

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018