BEUDAMED
    165 results · 12ms · Sources: EU EUDAMED, US FDA

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    Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

    FDA Recall
    Terminated ·Cygnus Medical·Product code MNL·March 17, 2016

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    FDA Recall
    Terminated ·Medline Industries Inc·Product code MNL·June 15, 2018

    First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    First Step Draco Pad, Product Number EP-4D

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·May 8, 2019

    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL

    FDA Recall
    Terminated ·Karl Storz Endovision, Inc.·Product code MNL·February 29, 2016

    First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code MNL·July 9, 2020

    Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·December 14, 2018

    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code MNL·April 25, 2019

    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·May 8, 2019

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·November 3, 2017

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

    FDA Enforcement
    Class I ·Terminated·Verathon, Inc.·December 19, 2012

    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·February 24, 2016