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

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    TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X3 TRIATHLON CS INSERT #3 9MM

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

    ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

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

    MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HOLLOW FIBER OXY WEST VERSION

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 12, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 19, 2011

    LIFECARE PCA

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code MEA·June 19, 2008

    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·September 3, 2014

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024