BEUDAMED
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    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

    iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.

    FDA Recall
    Terminated ·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015

    Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton.

    FDA Recall
    Terminated ·Eatonform Inc·Product code NQX·September 28, 2006

    3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.

    FDA Recall
    Terminated ·USA Instruments Incorporated·Product code MOS·September 20, 2006

    1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.

    FDA Recall
    Terminated ·USA Instruments Incorporated·Product code MOS·September 20, 2006

    USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure

    FDA Recall
    Terminated ·Non-Invasive Monitoring Systems, Inc.·Product code IRO·May 7, 2012

    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBL·August 29, 2013

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code LFL·April 30, 2013