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

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    MIM 5.2 (BRACHY)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUPERIOR-LOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304237155·

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304229761·

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304198586·

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2022

    PERICSCOPE, MODEL # PERISC1

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

    Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 26, 2011

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    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

    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

    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