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

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    OWL CANNULAE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957000011·R- Compact Sigma Lithotripter, 120V, 60 Hz

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 15, 2019

    VITEK 2 YEAST CASPOFUNGIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LUMALITE CURE LIGHT, MODEL 2100

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    GO BED PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 9, 2013

    ANTI-FYA

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 19, 2014

    ADJ WIRE COLLET 0.7-1.8MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 20, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    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

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ACCOLADE DR SL (Model L301)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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