BEUDAMED
    25 results · 22ms · Sources: EU EUDAMED, US FDA

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    SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AOS MODULAR FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    COMPR SRS PROX BDY - SM 48MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·July 25, 2025

    UNKNOWN TM BASEPLATE 25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 25, 2025

    UNKNOWN TM BASEPLATE 25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 24, 2025

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 3, 2013

    ATLAS PLUS DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    E1 44-36 STD HMRL BRNG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 25, 2025

    COMP RVS TRAY +5MM CO 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 25, 2025

    COMPR SRS MOD RGX AUG - SM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·July 25, 2025

    UNKNOWN 36MM GLENOSPHERE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 22, 2025

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    UNKNOWN 42MM SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 22, 2025

    UNKNOWN 42MM SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 22, 2025

    UNKNOWN 36MM GLENOSPHERE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 22, 2025

    UNKNOWN 36MM SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 22, 2025