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

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

    NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·November 15, 2017

    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Completed·ICU Medical, Inc.·October 10, 2018

    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·January 15, 2025

    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Enforcement
    Class II ·Completed·Hologic, Inc·December 18, 2024

    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

    FDA Enforcement
    Class II ·Completed·Epimed International·August 25, 2021

    NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

    FDA Enforcement
    Class II ·Completed·Epimed International·August 25, 2021

    AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·July 10, 2024

    Set Up Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015

    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

    FDA Enforcement
    Class II ·Completed·Vyaire Medical·June 21, 2023

    bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

    FDA Enforcement
    Class II ·Completed·Vyaire Medical·June 21, 2023

    Enteral Infusion Pump

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·April 14, 2021

    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Enforcement
    Class II ·Completed·Cook Incorporated·July 20, 2022

    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

    FDA Enforcement
    Class II ·Completed·Ventana Medical Systems Inc·June 17, 2020

    Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023