BEUDAMED
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    FOSSA URETERAL STONE SWEEPER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ROLLO 216X50X25E*31*SIEMENS.

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005810·

    CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX

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

    DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELLUME COVID-19 HOME TEST

    FDA Adverse Event
    Malfunction ·ELLUME LIMITED·Product code QKP·December 23, 2021

    ELLUME COVID-19 HOME TEST

    FDA Adverse Event
    Malfunction ·ELLUME LIMITED·Product code QKP·December 23, 2021

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·April 7, 2023

    NANOKNIFE SYSTEM

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

    ENDO STITCH SHORT INSTRUMENT

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code KOG·March 10, 2011

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FMF·March 25, 2008

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·September 26, 2022

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    Daig Livewire Steerable, Product Number 401904; 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