BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

    FDA 510(k)
    FDA Class 2 ·Dental

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197072700·Adson Retractor straig...

    PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BOSWORTH AIR POLISHER

    FDA 510(k)
    FDA Class 1 ·Dental

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 11, 2019

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 14, 2014

    SOPHY SM8 PROG. VALVE / ANTECHAMBER

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·May 22, 2013

    3M CAVILON NO STING BARRIER FILM PUMP

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code KMF·July 12, 2011

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 6, 2019

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 2, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 2, 2020

    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.

    FDA Recall
    Terminated ·MAST Biosurgery USA, Inc·Product code FTL·August 26, 2014

    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.

    FDA Enforcement
    Class II ·Terminated·MAST Biosurgery USA, Inc·February 18, 2015

    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022