BEUDAMED
    23 results · 27ms · Sources: EU EUDAMED, US FDA

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    VANTAGE TITAN 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973257·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973301·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970041·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970065·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970058·

    RINGLOC BI-POLAR 28X41MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·November 26, 2012

    28MM DIA COCR MOD HD -3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·November 26, 2012

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 2, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 8, 2008

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2022

    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

    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