BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    ACCU-CHECK COMBO SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAXCUT CARBIDE BUR (10/pk) FG 35

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811113531·MAXCUT CARBIDE BUR (10/pk) Shape: Inverted Cone...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448593·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450278024·

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·April 30, 2023

    NA

    FDA UDI
    David Scott Company·15060797552719·IMRIS Pad TX2-111353-000

    GOLDEN GATE ANTERIOR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

    BD ANGIO CATH

    FDA Adverse Event
    Injury ·BD·Product code FOZ·May 9, 2013

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LIT·September 23, 2014

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 25, 2022

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025