BEUDAMED
    272 results · 111ms · Sources: EU EUDAMED, US FDA

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    CRONO FIVE

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS·Product code FRN·November 29, 2017

    CRONO 5 PUMP

    FDA Adverse Event
    Injury ·INTRA PUMP INFUSION SYSTEMS·Product code FRN·November 24, 2017

    CRONO 5

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS·Product code FRN·December 3, 2018

    CRONO-5 PUMP

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS·Product code FRN·May 14, 2019

    CRONO 5 PUMP SYRINGE

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS·Product code FRN·May 8, 2019

    CRONO S-PID 50 PUMP

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEM·Product code FRN·February 26, 2020

    CRONO FIVE SYRINGE 20ML INTRA PUMP

    FDA Adverse Event
    Malfunction ·CANE' S.P.A·Product code FRN·March 31, 2020

    CRONO SUPER PID PUMP

    FDA Adverse Event
    Injury ·INTRA PUMP INFUSION SYSTEMS / CANE' S.P.A.·Product code FRN·October 20, 2021

    CRONO 5 SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEM / CANE' S.P.A.·Product code FRN·February 27, 2020

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    FDA Recall
    Terminated ·Intra Pump Infusion Systems·Product code FRN·October 18, 2013

    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

    FDA Enforcement
    Class II ·Terminated·Intra Pump Infusion Systems·October 29, 2014

    CRONO FIVE 2.5MG/ML

    FDA Adverse Event
    Malfunction ·CANE S.R.L. MEDICAL TECHNOLOGY/INTRA PUMP INFUSION SYSTEM·Product code FRN·October 22, 2018

    CRONO FIVE

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS / CANE' S. P. A.·Product code FRN·September 5, 2018

    CRONO FIVE 5MG/ML

    FDA Adverse Event
    Malfunction ·CANE' S. P. A. / INTRA PUMP INFUSION SYSTEMS·Product code FRN·September 5, 2018

    INF SET NERIA GUARD 60CM 9MM

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS/COVATEC, INC./UNOMEDICAL A/S·Product code FPA·January 12, 2026

    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.

    FDA Enforcement
    Class I ·Terminated·Iradimed Corporation·August 14, 2013

    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.

    FDA Recall
    Terminated ·Iradimed Corporation·Product code FRN·July 1, 2013

    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 22, 2012

    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 3, 2013

    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·July 14, 2010