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

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    611 ANKLE FUSION NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003247·1.6mm Pre-bent Plate, 4mm step, Right

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD220881300510·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD221081300510·10 3/4" Malis Bayonet Bipolar Forceps with Irri...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064071·1.6 OSA 4mm Pre-bent Right Plate Sterile Qty 2

    INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VERSABOARD, MODEL 7040

    FDA 510(k)
    FDA Class 2 ·Radiology

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

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 24, 2013

    ADVIA CENTAUR CP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·September 30, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 22, 2021

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 22, 2021

    GALAXY G3 2.5MM X 5CM

    FDA Adverse Event
    Death ·MEDOS INTERNATIONAL SARL·Product code KRD·October 14, 2020

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025