BEUDAMED
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    BIOMONITOR IV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464030538·EARQ F30 MINIRITE T C093

    GELPI SPINAL RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896026605·GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JCF·May 11, 2026

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JCF·May 11, 2026

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JCF·May 11, 2026

    SELF-RETAINING BICANALICULUS INTUBATON SET II

    FDA 510(k)
    FDA Unclassified ·Unknown

    SOFT-TOUCH TENS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    RA CATH SET: 22 GA X 1-3/8

    FDA Adverse Event
    Malfunction ·ARROW INTERNACIONAL INC·Product code DQO·November 7, 2008

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012