BEUDAMED
    18 results · 34ms · Sources: EU EUDAMED, US FDA

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    DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004

    FDA 510(k)
    FDA Class 2 ·Radiology

    PAQ.215X280X250*28*ELI200.MND

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763009993·

    Universal Mesh Medium

    FDA UDI
    SILVALEA LIMITED·05056387415703·

    Universal Mesh Large

    FDA UDI
    SILVALEA LIMITED·05056387415697·

    Universal Mesh Extra Small

    FDA UDI
    SILVALEA LIMITED·05056387415734·

    Universal Mesh Small

    FDA UDI
    SILVALEA LIMITED·05056387415710·

    Universal Mesh XXLarge

    FDA UDI
    SILVALEA LIMITED·05056387415741·

    Universal Mesh Extra Large

    FDA UDI
    SILVALEA LIMITED·05056387415727·

    ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

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

    GLENOID DRILL GUIDE HANDLE, LONG

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code MDM·March 29, 2021

    SERVO-I BASE UNIT

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·November 14, 2023

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    NATURAL-KNEE II STEMMED TIBIAL BASEPLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·January 9, 2013

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·July 9, 2014

    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015