BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    U2 Total Knee System, XPE Tibial Insert, PS PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 2, 2020

    X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TREVO RETRIEVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 15, 2021

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 13, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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