BEUDAMED
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    VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR

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

    PINNACLE®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046964200700·PINNACLE® Single Chamber Mixing Container, EVA ...

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006267·4500C SERIES NON HTD PNT

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 19, 2022

    EVA MIXING CONTAINER

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code KPE·September 25, 2019

    AERODR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    METAVISION CLINICAL INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·May 25, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 8, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 2, 2022

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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