BEUDAMED
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    EN-SNARE ENDOVASCULAR SNARE AND CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000291·1.6mm x 6mm OMI Orthodontic Anchor Screw

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    Acapella One

    FDA UDI
    Choice Spine, LP·10885862244864·

    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PURESPERM BUFFER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    TRULIANT TIB IMP PS INSERT SZ 3 12MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 5, 2023

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code OAB·March 15, 2013

    ILA 100-3.8 ANASTOMOTIC TITANIUM DLU

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·March 10, 2011

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·EBI·Product code KWQ·March 25, 2008

    CryoValve, Pulmonary Valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018