BEUDAMED
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    PC-ECG 1200

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·NORAV Medical Ltd.·1 device

    Pediatric ECG Electrodes belt

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    4 mm ECG adaptors

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    Levmed ECG limb electrodes

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

    FDA Enforcement
    Class II ·Terminated·Mazor Robotics Ltd·December 26, 2018

    10U Universal ECG Belt with Handles

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    AllBrand ECG Electrode Belt with Handles

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    Dedicated ECG Electrode Belt with Handles

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·4 devices

    Dedicated ECG Electrode Belt with Straps

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·4 devices

    6U Universal ECG Electrode Belt with Handles

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    6U Universal ECG Electrode Belt with Straps

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    FDA Enforcement
    Class II ·Terminated·Mazor Robotics Ltd·January 1, 2020

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    FDA Enforcement
    Class II ·Ongoing·Icecure Medical Ltd·October 11, 2023

    LevMed Universal Plus ECG Electrode Belt (ARs10U-LM) with straps

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·1 device

    Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVAIH

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025