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

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    AcrySof ReSTOR Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    AcrySof ReSTOR Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    AcrySof Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KRO·March 20, 2012

    Merit MAK Mini Access Kit, 4 French (1.3mm)

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DRE·July 20, 2004

    Merit MAK Mini Access Kit, 4 French (1.3mm)

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DRE·July 20, 2004

    Merit MAK Mini Access Kit, 4 French (1.3mm)

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DRE·July 20, 2004

    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·April 25, 2017

    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 15, 2017

    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.

    FDA Recall
    Terminated ·International Technidyne Corp·Product code FMK·January 23, 2006

    Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

    FDA Recall
    Terminated ·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005

    StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020

    FDA Recall
    Terminated ·Cook Inc.·Product code FFK·January 31, 2018

    Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061

    FDA Recall
    Terminated ·Richard Wolf Medical Instrument Corp·Product code FFK--·October 9, 2003

    ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM

    FDA Recall
    Terminated ·ACMI CORPORATION·Product code FFK·April 30, 2004

    Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFK·September 17, 2009

    LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA

    FDA Recall
    Terminated ·Electro Medical Systems (EMS SA) Rte de Champ-Colin·Product code FFK·October 3, 2003

    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FFK·March 10, 2020