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

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    Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HNO·June 8, 2007

    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

    FDA Recall
    Terminated ·Med-logics Inc·Product code HNO·January 13, 2015

    Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HNO·April 23, 2008

    Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HNO·April 23, 2008

    Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HNO·June 8, 2007

    Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.

    FDA Recall
    Terminated ·Wavelight AG Industriegebiet Doellnitz 5 Pressath Germany·Product code HNO·April 18, 2011

    Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    SKBM Microkeratome cutting tool

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code HNO·November 18, 2002

    Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    FDA Recall
    Terminated ·Philips Visicu·Product code DRG·March 10, 2016

    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    AUTION HYBRID AU-4050

    FDA Enforcement
    Class II ·Terminated·Arkray Factory USA, Inc.·June 26, 2019

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    FDA Enforcement
    Class II ·Terminated·Philips Visicu·May 4, 2016

    CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 5, 2020

    High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 5, 2020

    AUTION HYBRID AU-4050

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019