32 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·May 4, 2016
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 26, 2019
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