BEUDAMED
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    HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    TAPERLOC POR FEMORAL LAT 13.5X147

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·October 9, 2013

    TAPERLOC POR LAT FEMORAL 12.5X145

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·October 9, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·March 21, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 31, 2008

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 31, 2012

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 31, 2012

    M2A-MAGNUM 42-50MM TPR INSRT-3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 31, 2012

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 1, 2022

    M2A 1 PIECE SHELL 38MMX52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 13, 2013

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018