BEUDAMED
    17 results · 30ms · Sources: EU EUDAMED, US FDA

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    SYNTHES HEMOSTATIC BONE PUTTY (HBP)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450435434·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520424·Split Tube Retractor, Size Ø16x40 mm

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110054·Trial Procedure Kit

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964092145·Trial Procedure Kit

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110061·Trial Procedure Kit

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110030·Trial Procedure Kit

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110047·Trial Procedure Kit

    ISOLA CLOSED DUAL ROD CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROJET CRONO PCA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    ACCU-CHEK RAPID D INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·May 18, 2011

    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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 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