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

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    DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEEK PREVAIL™ Cervical Interbody Device

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994502094·IMPLANT 4210664 STANDALONE 16 X 14 X 6MM

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133852·LATERAL,120MM CYLINDRICAL

    COPELAND RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    GALAXY G3 MINI 2MM X 6CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 23, 2020

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIQ·October 23, 2008

    UNKNOWN NEXGEN KNEE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·August 10, 2011

    RIATA ACTIVE FIXATION

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

    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

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020