BEUDAMED
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    Filters Classification: Class Iii × Status: Terminated × Clear all

    ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106389-004 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in 2106389-005 ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106389-006 ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106390-001 ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in 2106390-002 ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in 2106390-003 ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in 2106390-004 ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in 2106391-001 ECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in 2106391-002 ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in 2106391-003 ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in 2106391-004 ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in 2106391-005 ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106391-006 ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106393-001 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in 2106393-002 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in 2106393-003 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in 2106393-004 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in 2106397-001 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106397-002 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106397-003 ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106398-001 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106398-002 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·August 3, 2016

    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·July 5, 2017

    AIA-PACK TPOAb CONTROL SET

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·June 7, 2017

    AIA-PACK TgAb CONTROL SET

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·June 7, 2017

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    FDA Enforcement
    Class III ·Terminated·Ultradent Products, Inc.·February 20, 2013

    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

    FDA Enforcement
    Class III ·Terminated·Ultradent Products, Inc.·February 20, 2013

    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001

    FDA Enforcement
    Class III ·Terminated·Canadian Hospital Specialties·November 23, 2022

    Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·April 26, 2017

    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·August 29, 2012

    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·March 1, 2017

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    FDA Enforcement
    Class III ·Terminated·Tosoh Smd Inc·January 1, 2020

    KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

    FDA Enforcement
    Class III ·Terminated·Microbiologics Inc·February 9, 2022

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

    FDA Enforcement
    Class III ·Terminated·Neomed Inc·December 12, 2018

    Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

    FDA Enforcement
    Class III ·Terminated·Cook Medical Incorporated·April 13, 2022

    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918

    FDA Enforcement
    Class III ·Terminated·Cook Medical Incorporated·April 13, 2022