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

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    RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    EZ-COMFORT TRANSPORTER 2000 SERIES

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·May 1, 2013

    X-FORCE BALLOON DILATION CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC.C.R. BARD, INC (COVINGTON)·Product code EZN·August 28, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 23, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    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

    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

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015