BEUDAMED
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    SURGERY DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517137005·Helix R Plate, 88mm 4-Level

    0800,APS0,10,3,N,L1,L2 NV,TB

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828149907·0800,APS0,10,3,N,L1,L2 NV,TB

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209101993·KIT, BIOLOGICAL PERSONAL PROTECTION

    VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081

    FDA 510(k)
    FDA Class 2 ·General Hospital

    L3C1950 - UNO OR/SECUREMENT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code KGX·June 29, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·October 22, 2012

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 12, 2010

    Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·September 2, 2010

    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·March 10, 2011

    SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·July 17, 2009

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021