BEUDAMED
    35 results · 17ms · Sources: EU EUDAMED, US FDA

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

    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

    FDA Enforcement
    Class II ·Ongoing·Implant Resource Inc·October 27, 2021

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    FDA Enforcement
    Class II ·Ongoing·Aesculap Implant Systems LLC·May 3, 2023

    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·June 28, 2023

    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 17, 2024

    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 17, 2024

    Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·May 13, 2026

    ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·October 30, 2019

    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023

    Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA

    FDA Enforcement
    Class II ·Ongoing·Microcare Medical·October 2, 2024

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019