BEUDAMED
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    UNITED STEM, PSA TYPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Carbide rotary dental burs

    FDA UDI
    PRIMA DENTAL MANUFACTURING LIMITED·05056020711759·

    NITANIUM® INTRUSION ARCHWIRE

    FDA UDI
    Ortho Organizers, Inc.·00190707067335·.016 X .022 Upper/Long Nitanium® Intrusion Arch...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450585306·

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00811801031502·Aggressive Endplate Scraper - Straight

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. S.A, DE C.V.·Product code GDO·September 30, 1999

    GSA GENITO SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology

    CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code HXX·May 24, 2011

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 6, 2024

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015

    General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

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