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

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    IVAS 2-10MM (10 GUAGE) BALLON CATHETER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814756·GENUMEDI EXTRA WIDE SAND SIZE VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520271·Split Tube Retractor, Size Ø12x90 mm

    CYSTOSCOPES

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

    MICROJET QUARK, MODEL U100 OR U40

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALL SET GOLD DRB1 SSP UNITRAY KIT

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORP.·Product code MZI·October 15, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2023

    ALLSET GOLD SSP HLA-DRB1 HIGH RES KIT

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 23, 2014

    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 REVEL INSULIN INFUSION PUMP

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

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH LTD./HUNTINGTON·Product code HQL·May 18, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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

    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