BEUDAMED
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    CHLORAPREP

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854005132·ULTRAPOWER BUR, ROUND(COPPER), 7.5 MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450156162·

    3D HDRAULIC FINE MICROMANIPULATOR MO-188NE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    METHADONE MICROPLATE EIA URINE APPLICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RESONANCE STENT SET

    FDA Adverse Event
    Injury ·COOK MEDICAL IRELAND·Product code FAD·April 11, 2025

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 8, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code LGW·October 8, 2013

    M2A-38 CUP NON FLARED SIZE 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 15, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 26, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 16, 2011

    ROTABLATOR CONSOLE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code MCX·March 27, 2008

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 6, 1998

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 30, 2021

    RESONANCE STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FAD·April 9, 2025

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 11, 2021

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016

    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