BEUDAMED
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    INTROCAN SAFETY IV CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854009437·ULTRAPOWER BUR, ROUND END (RED), 3.2 MM X 15.2 MM

    SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GDC POWER SUPPLY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·March 15, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    ISOMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008

    PROCISE XP COBLATOR II

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·February 11, 2021

    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 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