BEUDAMED
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    Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Intraoral Scan Body RP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075168·

    DENALI

    FDA UDI
    ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042120372·Hook Crimping Plier

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154810·WHITNEY 4deg 36mmx13mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154841·WHITNEY 4deg 36mmx19mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154858·WHITNEY 4deg 36mmx21mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154827·WHITNEY 4deg 36mmx15mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154834·WHITNEY 4deg 36mmx17mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154803·WHITNEY 4deg 36mmx11mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154797·WHITNEY 4deg 36mmx9mm

    BELLEGLASS HP TRANSLUCENT DENTIN

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 3, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    DAIGLER KUNSTSTOFFSPRITZEREI GMBH·Product code IKX·October 24, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021