31 results
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33ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
FDA Enforcement
Class II
·Completed·Innomed, Inc.·May 8, 2024
Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
FDA Enforcement
Class II
·Terminated·Data Innovations, Inc.·January 1, 2014
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020