BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005398·COSMETIC 20/40 LL CUSP 022 T-11 A+5 R2M

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425648429·CIRCUMCISION TRAY

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

    FDA 510(k)
    FDA Class 2 ·Dental

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2021

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO JUNCOS·Product code LGW·March 20, 2026

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 26, 2012

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 2, 2013

    HEMODIALYSIS TWO-LUMEN KIT: 2-L 28FR

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code MSD·March 20, 2013

    SPRINT FIDELIS

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

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 26, 2008

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    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