BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    Cios Flow

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528114247·T15 SCREW HOLE LOCKING DRILL GUIDE

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113790·AIR INJECT CANNULA 27GA 22MM

    16PW - Loggers - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

    MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RT-PLUS MODULAR CEMENTED KNEE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 24, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GCJ·October 17, 2008

    ATLANTIS (TM) SR PRO

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·August 11, 2011

    NEU_UNKNOWN_PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 22, 2025

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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