BEUDAMED
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    GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SMR REVERSE HUMERAL BODY SHORT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·July 5, 2021

    OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/COM/U240 9153637785

    FDA Adverse Event
    Injury ·DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.·Product code IOR·October 11, 2016

    L3W0250 - KALTOSTAT

    FDA Adverse Event
    Malfunction ·CONVATEC LTD·Product code NAC·August 8, 2022

    ENDO RETRACT II 10MM INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC P·Product code GCJ·March 15, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 21, 2011

    CELL-DYN WBC REAGENT A

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·March 18, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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