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

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    CRIT-LINE MONITOR III (CLM III)

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

    Preat

    FDA UDI
    Preat Corporation·00842092170908·ASC Biomet 3i Certain®-compatible 4.1mm Engagin...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00170631·

    ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX

    FDA UDI
    CLIKTECH LLC·00856200001763·ClikRay Size I/O Camera Sleeves fits DexCam 3 -...

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 28, 2026

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·July 9, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 13, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·February 25, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 19, 2008

    HERO GRAFT

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·December 23, 2014

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024