BEUDAMED
    51 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Article No. NA6050411, Valiant PhD No. 1 Econo

    FDA Enforcement
    Class II ·Ongoing·Ivoclar Vivadent, Inc.·February 14, 2024

    Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·June 15, 2022

    Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

    FDA Enforcement
    Class II ·Ongoing·Becton, Dickinson and Company, BD Bio Sciences·January 1, 2025

    Impella 5.5 Set AU; Product Code: 1000361;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·June 10, 2026

    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·February 19, 2025

    THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·October 18, 2023

    MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Impella CP Smart Assist Set; Product Code: 1000402;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    FDA Enforcement
    Class II ·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025

    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024