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

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    CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139234088·Acetabular Trial Ø61

    Innospire Deluxe

    FDA UDI
    VEGA TECHNOLOGIES INC.·06946159502115·1110061

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521110061D0·10 x 60 mm SI Implant Fully Threaded with HA Co...

    CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKN ANTHOLOGY HIP IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 30, 2020

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 13, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 23, 2014

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 1, 2011

    DREAMSTATION CPAP PRO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code BZD·March 22, 2022

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    BIRMINGHAM HIP MODULAR HEAD (BHMH)

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWL·May 30, 2020

    UNKN R3 SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·May 30, 2020

    R3 METAL LINER IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·May 30, 2020

    Video Cystoscope models ECY-1570 and ECY-1570K

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·February 21, 2018

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024