BEUDAMED
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    ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613052751·White Nylon Tube Brushes, Brush Diameter 11mm x...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111087714·OP SCISS STR S/S 4.5"

    Zavation

    FDA UDI
    Zavation LLC·00842166176652·Tab Remover

    Zavation

    FDA UDI
    Zavation LLC·00842166176669·Tab Remover

    CENTRO FAMILY OF MANUAL WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AEROLET TOILET LIFT, MODEL AER-01

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    PELVICOL (BARD) 8CM X 12CM

    FDA Adverse Event
    COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·May 21, 2013

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 16, 2011

    TRU CC FEMORAL SIZE 1 LEFT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 15, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015