BEUDAMED
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    MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    Hydro-Surg

    FDA UDI
    Davol Inc.·00801741077012·Quick-Disconnect Probe Tip without Irrigation H...

    Altus Spine Cervical Interbody Fusion System

    FDA UDI
    Altus Spine, LLC·00843210131245·Rasp, W/Tab

    WIRE END CUTTER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051515·WIRE END CUTTER TUNGSTEN CARBIDE BLADES

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038788·sEEG ANCHOR BOLT DRILL/DRIVER BUSHING, FOR 2.4M...

    AO

    FDA UDI
    STRYKER CORPORATION·04546540216403·1:1 Small Drill

    BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·September 2, 2025

    BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·February 7, 2025

    MEDCOMP BIO-CATH CATHETER LINE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANISEIKONIA INSPECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BD PHASEAL¿ PROTECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·December 14, 2021

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·May 9, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    PERIFIX FX

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC·Product code CAZ·May 5, 2011

    Stryker Ortholock EX Pin for use with the Stryker Navigation System, 3 mm x 110 mm, Stryker, Kalamazoo, MI; Part 6007-103-110. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·June 5, 2008

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024