BEUDAMED
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    Neurescue device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039570·LEKSELL-T-DRIVER UPPER GUIDE BUSHING, FOR 2.7MM...

    OFFSET ACETABULAR

    FDA UDI
    Biomet Orthopedics, LLC·00880304450264·

    REGENEREX HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304450233·

    25-0101 ST NEEDLE CTR DBL MAG 20CT 1PK

    FDA Adverse Event
    Injury ·DEROYAL·Product code MMK·September 20, 2000

    VENODYNE V810

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIGIL SEROLOGY CONTROL LEVEL C

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    530G INSULIN PUMP

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

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 9, 2011

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·KANAE CO.,LTD.·Product code KDJ·July 8, 2013

    UNKNOWN STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 4, 2018

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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