BEUDAMED
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    BPA-FREE MICROHYBID COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    JOBST soSoft

    FDA UDI
    BSN MEDICAL, INC.·00035664007416·SOSOFT 8-15 MM HG KNEE HIGH BROCADE SMALL BLACK...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1202370·

    DIALYSATE METER, MODEL D-6

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 16, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 14, 2020

    AROX 53-BP

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DTB·May 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code JXG·June 7, 2011

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024