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

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    BARCO MAMMO TOMOSYNTHESIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ScrewPlant® GPS® Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307114567·

    MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRYKER HEATED INSUFFLATOR TUBE SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    530G INSULIN PUMP

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

    INNOVA 3100

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS·Product code MQB·May 19, 2011

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·January 14, 2019

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·September 25, 2014

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·March 11, 2015

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Other ·SURGIQUEST, INC.·Product code HIF·December 12, 2013

    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

    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