BEUDAMED
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    NuVasive AttraX Scaffold

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522405070·

    SilverGlide

    FDA UDI
    STRYKER CORPORATION·04546540696090·ProSeries Non-stick Bipolar Electrosurgical For...

    TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HIOSSEN PROSTHETIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 10, 2014

    IDENTITY SR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011

    1.55MM X 10MM TWIST DRILL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019