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

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    HEMOCHRON JR. CITRATE APTT CUVETTE

    FDA 510(k)
    FDA Class 2 ·Hematology

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193101859·EVOS Straight HA PEEK 8mm x 9mm x 22mm Flat, 5°...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409073009·Neck Trial Extended Size 10-12

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158218413·SCISSOR VANNAS OPHTHALMIC STRAIGHT FLAT HANDLE ...

    NA

    FDA UDI
    STERILMED, INC.·10888551027946·DRILL BIT TWIST

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154183937·Drill for 8mm Screws, Stryker Shaft

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe

    STRESS GUARD, MODEL HERDEV1

    FDA 510(k)
    FDA Class 2 ·Neurology

    AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTACT DETACH

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025

    GOOD SAM CINCINNATI OH 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

    MINI PCA EXT SET 67IN NDEHP W/INJECTOR

    FDA Adverse Event
    Injury ·HOSPIRA LTD.·Product code MEA·April 28, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    OPTISENSE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2008

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021