BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047278·NGS NARROW TAPERED DRILL

    SELF CENTERING

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295003472·SELF CENTERING BI-POLAR HEAD 28mm ID 57mm OD

    MEDIUM 199, 10X, CATALOG NO. 210-3557

    FDA 510(k)
    FDA Class 1 ·Hematology

    LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·September 16, 2024

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·May 24, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 9, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2014

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·May 26, 2011

    NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·February 25, 2025

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021