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    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·July 5, 2017

    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·August 1, 2012

    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    FDA Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·December 6, 2023

    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.

    FDA Enforcement
    Class III ·Terminated·GETINGE US SALES LLC·May 1, 2019

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR HF 4-WAY STPCK 135 IN.; Catalog Number: 490193. 2. IV AD SET, 2 CARESITE, SAFEPORT, 134 IN.; Catalog Number: 490326.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 116 IN; Catalog Number: 490522. 2. IV ADMIN SET 115, IN. W. 9 IN EXT SET; Catalog Number: 490568.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 130 IN; Catalog Number: 477002. 2. IV ADMIN SET 85 IN.; Catalog Number: 477017.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTRAPORT,134 IN.; Catalog Number: 490312. 2. IV ADMIN SET W/ 15 DROPS/ML, 120 IN.; Catalog Number: 490432.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML, 105 IN.; Catalog Number: 490242. 2. IV ADMN SET W/15 DROP,2 CARESITE,142 IN.; Catalog Number: 490311. 3. IV ADMIN SET W/15 DROPS/ML 115 in.; Catalog Number: 490353.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks; Catalog Number: 354210. 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN.; Catalog Number: 490389.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 117 IN.; Catalog Number: 490468.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025