BEUDAMED
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    S2 TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROLLO 210X25X16I/QT-HS/

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763079736·

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005329·COSMETIC 20/40 UR BIC 022 T-7 A=0 R2D

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854006573·ULTRAPOWER BUR, ROUND(RED), 4 MM

    MODIFICATION TO XIA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORTAFLEX SURGICAL SLING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    C-T II PORT CLOSURE, 10/15(MM)

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HET·March 20, 2013

    MAXCEM ELITE

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

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE SJ·Product code JPA·March 28, 2008

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    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