BEUDAMED
    61 results · 14ms · Sources: EU EUDAMED, US FDA

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    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·May 15, 2023

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OES·May 18, 2023

    Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKG·April 8, 2024

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    FDA Recall
    Open, Classified ·Philips Healthcare·Product code OWB·September 24, 2021

    ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code DDR·February 21, 2024

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Recall
    Open, Classified ·Hycor Biomedical Inc·Product code DHR·March 19, 2018

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·May 12, 2026

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    FDA Recall
    Open, Classified ·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025

    2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code ERA·May 9, 2025

    Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Merlin PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code OSR·March 10, 2022

    SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

    FDA Recall
    Open, Classified ·Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany·Product code MUJ·October 17, 2023

    Merlin 2 PCS MER3700 programmer Model MER3400 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code NIK·March 10, 2022

    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code JBP·November 5, 2025

    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

    FDA Recall
    Open, Classified ·Cell Marque Corporation·Product code NJT·July 15, 2021

    Epix Universal Clip Applier, REF: CA500, STERILEEO

    FDA Recall
    Open, Classified ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MDM·January 30, 2024

    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code FMF·March 4, 2025

    SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code CAH·June 16, 2025