BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    SA FLOWABLE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434564·Tasso+ convenience kit allows self-collection o...

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158217553·CLAMP HARKEN ATRAUMA AURICLE DOUBLE CURVE 9.5"

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556651·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502733·Gutta Percha Points is used to root canal filin...

    ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

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

    GENTLECATH GLIDE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·June 5, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    VERCISE CARTESIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 18, 2023

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 1, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·May 20, 2011

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·August 8, 2008

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 3, 2025

    Vail Enclosed Bed System, model 2000

    FDA Recall
    Terminated ·Vail Products Inc·Product code FNL·April 1, 2003

    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