BEUDAMED
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    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Enforcement
    Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Enforcement
    Class II ·Terminated·SA3, LLC·April 13, 2022

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Enforcement
    Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code NBW·January 29, 2004

    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Enforcement
    Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 9, 2021

    Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 9, 2021

    Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 9, 2021

    Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·February 3, 2021

    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 5, 2019

    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 5, 2019

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·May 27, 2020

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·May 27, 2020

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·May 27, 2020