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

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    BIOGRAPH MMR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957004118·Genesis Urology Imaging System, Right, FPD, 80 ...

    ACTAEON PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRESIDIO 10 CERE 5MMX17CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·December 28, 2021

    DXTEND STAND PE CUP D38 +9MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KWS·November 10, 2014

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 26, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 17, 2023

    PRESIDIO 10 CERE 6MMX26CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·May 10, 2021

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021