BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    RAPID ONE STEP BUPRENORPHINE TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELPHA 4 CONTI

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    PRISMAFLEX SETS (HF)

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 22, 2023

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 4, 2013

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JID·April 7, 2011

    VITALITY DS

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    INFUSOMAT SPACE PUMP IV SET

    FDA Adverse Event
    Malfunction ·B. BRAUN DOMINICAN REPUBLIC·Product code FPA·November 17, 2009

    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·March 28, 2023

    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·February 19, 2025

    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025

    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·May 10, 2023

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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