BEUDAMED
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    MEDSOURCE IV ADMINSTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030634·Basin Set, St. Joe

    Nebulizing Elbow

    FDA UDI
    Respironics, Inc.·00606959034426·EE Nebulizing Elbow Kit, Single, USA

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1204240·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193532·

    DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LARGE PATCH LEAD L67

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code LWS·July 8, 1997

    ASCENDRA INTRODUCER SHEAT SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·May 20, 2013

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    FLOCONTROL

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code HRX·May 27, 2011

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·October 18, 2012

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 9, 2013

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 16, 2013

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2013

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 8, 2025

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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

    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