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

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    APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NeuroPEN

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00613994908490·NEUROPEN 2120-035 15MM 19CM DF

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037300763·DOUBLE TAPER TA6V +5 mm +/-3°

    Spo2 Probe (Older AngioNew® V and VI)

    FDA UDI
    VASOMEDICAL, INC.·00817980021334·Spo2 Probe (Older AngioNew® V and VI)

    RIVA Posterior Fixation System

    FDA UDI
    XENIX MEDICAL LLC·00840493418568·CONSTRAINED LORDOTIC ROD, 5.5mm x 35mm

    RIVA Pedicle Screw System

    FDA UDI
    XENIX MEDICAL LLC·00840493418773·CONSTRAINED LORDOTIC ROD, 6.0mm x 35mm

    SLEEK OTW PTA CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL VISULAS 532S LASER WITH THE VITE OPTION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 3, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 26, 2011

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    FDA Enforcement
    Class II ·Ongoing·G & H Wire Company·February 14, 2024

    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)

    FDA Recall
    Terminated ·Product code FGE·July 9, 2004

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025