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

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    Ohlendorf Clear Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    Anti-P1 (P1)

    FDA UDI
    DIAGAST·23661562105407·Blood Grouping Reagent, Anti-P1 (Murine Monoclo...

    Ti-one 101

    FDA UDI
    HUNG CHUN BIO-S CO., LTD.·04719871590393·Abutment Ø5.5, 4.0 mm Abt. H The Ti-one 101 Den...

    STARTER GUIDEWIRE

    FDA Adverse Event
    Malfunction ·LAKE REGION MEDICAL LIMITED·Product code DQX·December 3, 2021

    Inertia® Pedicle Screw and Deformity Correxxion® System

    FDA UDI
    NEXXT SPINE, LLC·00889929027233·MAC Pedicle Screw, Ø10.5x40 mm

    EUROPA™ Pedicle Screw

    FDA UDI
    MIRUS LLC·00810025483012·Ø10.5 X 40mm EUROPA™ Pedicle Screw

    TERUMO SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2016

    BD BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 28, 2021

    MAKOplasty Hip Array Kit Laminate 150230

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·May 11, 2016

    ON-Q PAINBUSTER SOAKER 6.5, 270ML VOL X 5 ML/HR

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·August 10, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014

    UNIFY QUADRA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    MAKOplasty Hip Array Kit Laminate 150230

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·November 25, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015