BEUDAMED
    108 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 4, 2019

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems Inc.·February 14, 2018

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·May 21, 2014

    Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·November 30, 2016

    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Wfr/aquaplast Corp·April 6, 2016

    ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 21, 2018

    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 21, 2018

    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 6, 2017

    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·July 29, 2020

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·May 24, 2023

    HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·December 27, 2023