BEUDAMED
    11 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·May 21, 2024

    BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·February 11, 2026

    BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·November 6, 2025

    BD Alaris PCU REF 8015

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·September 15, 2023

    Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·January 24, 2023

    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code PHC·February 18, 2025

    BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code PHC·February 18, 2025

    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.

    FDA Recall
    Open, Classified ·GRAPHENANO DENTAL SL Calle De Pau Casals·Product code EBI·October 24, 2023

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    FDA Recall
    Open, Classified ·Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804·Product code NZU·October 23, 2023

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    FDA Recall
    Open, Classified ·Lacrimedics Inc·Product code LZU·January 17, 2022

    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

    FDA Recall
    Open, Classified ·Lacrimedics Inc·Product code LZU·January 17, 2022