BEUDAMED
    26 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517578327·CoRoent Ant TLIF Ti 10x12x32mm 0°

    Elite HD+ Maxi Tray Material Fast Set

    FDA UDI
    ZHERMACK SPA·EZHIC2023201·Addition silicone impression material

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184049·Accufit Molar Bands Lower Left Second Molar 32

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327291377·PEDIATRIC MANDIBULAR DISTRACTOR 2

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH

    ACCOLADE C FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 7, 2023

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·August 2, 2011

    ROCHE COAGUCHECK XS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 3, 2013

    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 17, 2023

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 8, 2021

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·August 20, 2025

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·August 20, 2025

    CD HORIZON® BALLAST¿ SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·February 6, 2024