BEUDAMED
    43 results · 33ms · Sources: EU EUDAMED, US FDA

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    NEUROLINK IP MODEL: PK1117

    FDA 510(k)
    FDA Class 2 ·Neurology

    Bur PM2-MIS P160 diam Ø4.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055512137·

    Oticon

    FDA UDI
    Oticon A/S·05707131163578·ACTO, RITE TC

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·March 20, 2026

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042806·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462078·Bone Chisel Squared Handle Steel D 2.5mm, WL 2...

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·February 26, 2026

    ESTHETICA

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFIED SINGLE AXLE TOTAL ELBOW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REMSTAR PRO C-FLEX+

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·May 18, 2011

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    FDA Enforcement
    Class II ·Terminated·Primus Corporation·November 11, 2020

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017