BEUDAMED
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    ATRILITY MEDICAL, INC.

    FDA registration
    ATRILITY MEDICAL, INC.·2 products·🇺🇸 United States

    St. Jude Medical, Atrial Fibrillation Division, Inc.

    FDA registration
    St. Jude Medical, Atrial Fibrillation Division, Inc.·24 products·🇺🇸 United States

    St. Jude Medical, Atrial Fibrillation Division, Inc.

    FDA registration
    St. Jude Medical, Atrial Fibrillation Division, Inc.·18 products·🇺🇸 United States

    CRILE FORCEPS CVD 140MM

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code HRQ·December 8, 2023

    Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DRA·May 21, 2008

    ANGIO-SEAL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.·Product code MGB·April 19, 2024

    SWARTZ SL0

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.·Product code DYB·October 27, 2023

    AVEIR LEADLESS PACEMAKERS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.·Product code PNJ·December 22, 2023

    Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb, Inc.·January 18, 2017

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    FDA Enforcement
    Class I ·Terminated·H & H Associates·October 9, 2013

    St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA

    FDA Recall
    Terminated ·St. Jude Medical Atrial Fibrillation Division Inc·Product code OCL·June 15, 2009

    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

    FDA Recall
    Open, Classified ·St. Jude Medical, Atrial Fibrillation Division, Inc.·Product code OAE·December 18, 2023

    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Atrial Fibrillation Division, Inc.·January 31, 2024

    CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code GDM·April 6, 2009

    RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

    FDA Recall
    Terminated ·Rita Medical Systems, Inc.·Product code GEI·April 3, 2007

    RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

    FDA Recall
    Terminated ·Rita Medical Systems, Inc.·Product code GEI·April 3, 2007

    RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

    FDA Recall
    Terminated ·Rita Medical Systems, Inc.·Product code GEI·April 3, 2007

    OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.

    FDA Recall
    Terminated ·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009

    Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.

    FDA Recall
    Terminated ·Heart Sync, Inc·Product code LDF·April 26, 2013

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

    FDA Recall
    Terminated ·Progressive Medical Inc·Product code GEI·April 12, 2013