BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

    FDA Enforcement
    Class II ·Terminated·Novapproach Spine LLC·November 23, 2022

    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

    FDA Enforcement
    Class II ·Ongoing·Fridababy LLC·February 19, 2020

    Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

    FDA Enforcement
    Class II ·Terminated·Heraeus Kulzer, LLC.·May 28, 2014

    Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·July 10, 2024

    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·May 6, 2015

    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    FDA Enforcement
    Class II ·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·May 18, 2022

    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 7, 2018

    Basic Biopsy Tray, Item Number NMBP44L

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 24, 2013

    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 24, 2013

    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·May 22, 2024

    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

    FDA Enforcement
    Class II ·Ongoing·Thoratec Corp.·December 8, 2021

    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·November 18, 2015