BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    CELL-CHEX WITH CPPD CRYSTALS

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLEXI-SITE SP02 EAR SENSOR

    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

    IDRIVE

    FDA Adverse Event
    Injury ·POWER MEDICAL INTERVENTIONS·Product code GDW·October 23, 2008

    COLLEAGUE PRE P1.7

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

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

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

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

    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

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014