BEUDAMED
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    REFORM PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377320·Integra® Jarit® Ryder Needle Holder, 6-1/4", Ca...

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010062451·AMBI SUPRACONDYLAR PLATE 12 SLOT 244MM 90D

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973875·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973790·

    RDT3 HANDPIECE HEAD MODEL RDT3

    FDA 510(k)
    FDA Class 1 ·Dental

    RSV OIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 14, 2018

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·May 20, 2013

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    GEMINI ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 4, 2011

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·September 18, 2024

    EQUINOXE REVERSE 42MM HUMERAL LINER +0

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 10, 2024

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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