BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    FDA Enforcement
    Class II ·Terminated·Southern Implants, (Pty.) Ltd.·April 25, 2018

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Cocoon Convective Warming System, Product Code: CWS5000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Enforcement
    Class II ·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023

    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

    FDA Enforcement
    Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024

    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

    FDA Enforcement
    Class II ·Ongoing·Leica Biosystems Melbourne Pty Ltd·May 7, 2025

    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

    FDA Enforcement
    Class II ·Terminated·Bradshaw Medical Inc.·May 18, 2016

    Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,

    FDA Enforcement
    Class II ·Ongoing·Vascutek, Ltd.·March 11, 2026

    NOxBOXi Nitric Oxide Delivery System

    FDA Enforcement
    Class II ·Ongoing·NOXBOX LTD·September 17, 2025

    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·August 27, 2025

    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·March 12, 2025

    Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.

    FDA Enforcement
    Class II ·Ongoing·Augmedics Ltd.·May 21, 2025

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Enforcement
    Class II ·Ongoing·IDS LTD·January 15, 2025

    OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

    FDA Enforcement
    Class II ·Ongoing·OrganOx Ltd·November 27, 2024