BEUDAMED
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    ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KAYE BLEPHAROPLASTY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896020528·KAYE BLEPHAROPLASTY SCISSORS CURVED TUNGSTEN CA...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756169493·RANGE MASTER™

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383504164·Gutta Percha Points is used to root canal filin...

    SA FLOWABLE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

    PINN CAN BONE SCREW 6.5MMX30MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·May 19, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    CONTOUR CURVED CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 11, 2008

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·June 18, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·June 18, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·June 18, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·June 18, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·June 18, 2025

    ABIOMED 23F INTRODUCER KIT FOR IMPELLA

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DYB·June 8, 2018

    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019