BEUDAMED
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    MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496020196·VENERE 100, SIZE L, SABBIA, GRADUATED COMPRESSI...

    DM MS Sim.LED ExL DE

    FDA UDI
    S.I.M.E.O.N. Medical GmbH & Co. KG·04250613849282·

    ROSA® Knee

    FDA UDI
    Orthosoft Inc·00887868552175·

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 10, 2012

    ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

    FDA 510(k)
    FDA Class 2 ·Immunology

    LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·April 24, 2026

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 24, 2026

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 29, 2013

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 21, 2014

    HT COMMAND

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·March 25, 2013

    GIA 80-4.8 SINGLE USE RELOADABLE STAPLER

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·March 7, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2008

    Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·September 16, 2020

    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