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

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    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code BSZ·June 24, 2010

    Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018".

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code BSZ·June 25, 2009

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·March 7, 2013

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code FPX·July 18, 2013

    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code ODX·August 11, 2011

    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code OCX·January 14, 2015

    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·February 17, 2015

    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020