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

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    GLYCOSAL II HBA 1C TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012567·Zirlux 16+ 0M2 95X25

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450230862·

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033338988·

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033346310·

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339008·

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033338995·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve

    SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 7, 2026

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 19, 2026

    CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·March 19, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 14, 2011

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·March 10, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023