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

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    HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

    FDA 510(k)
    FDA Class 2 ·Hematology

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    ROLLO 210X20X16E/QT-HS80/ELI230

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005735·

    MICROPOWER

    FDA UDI
    Conmed Corporation·20845854013172·MICROPOWER SAGITTAL SAW, PERMANENT LEVER

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005251·COSMETIC 20/40 UL CEN 022 T+12 A+5 R=0

    NANNINI ITALIAN QUALITY SRL

    FDA registration
    NANNINI ITALIAN QUALITY SRL·3 products·🇮🇹 Italy

    MICROPOWER

    FDA UDI
    Conmed Corporation·10845854013175·Micropower Sagittal Saw, Permanent Lever

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab

    BIOUNIVERSAL PDF

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

    FDA 510(k)
    FDA Class 2 ·Immunology

    IAB : 8 FR - 40 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·March 20, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 16, 2011

    MATRIX2 360 DEGREES SOFT SR COIL

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION·Product code HCG·March 27, 2008

    Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 24, 2019

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 13, 2022

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 8, 2024

    OLYMPUS ENDO CAPSULE

    FDA Adverse Event
    Injury ·OLYMPUS CORPORATION OF THE AMERICAS·Product code NEZ·May 17, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014