BEUDAMED
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    VitreJect Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464030507·EARQ F30 MINIRITE T C090

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540177438·BIPOLAR FORCEPS

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020850·INTRG WHISP-Z MBT 2BIC HK -17T 0A 022 LL

    GELPI SPINAL RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896026575·GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP

    Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONNECTION CABLE WL 3M

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code GEY·October 4, 2024

    CONNECTION CABLE WL 3M

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code GEY·October 4, 2024

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 16, 2013

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 5, 2025

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    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