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

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    MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496063223·SOCKS FOR YOU BAMBOO POIS, SIZE XXL, NERO, GRAD...

    GEON DIGITAL CLINICAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    X3 TRIATHLON CS INSERT #3 9MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

    SYRINGE 5ML SALINE FILL CHINA SP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 9, 2021

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 26, 2013

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·June 17, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011

    ARCHITECT IPTH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021