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

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    SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SCOTT'S SELECT K-FILES 6/pk 25mm # 25

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811225251·ENDODONTIC K-FILES (6/pack) Length: 25mm, Size:...

    Kellan Hydrodissection Cannula, 25ga

    FDA UDI
    KATALYST SURGICAL LLC·00840096205657·Kellan Hydrodissection Cannula, 25ga

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002800·OP/OD 2.5mm Finishing Drill

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094012254·Stockinette Tubular 2"x25" 1ply

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506057649·FORCEP HEANEY TISSUE, 3X4 TEETH, 7.5IN

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

    STONYBROOK HSP NY NY 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

    CONQUEST 40 PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·May 16, 2013

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 22, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 13, 2011

    C21785 IT TREVISO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024