BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    Orthodontics Bracket

    FDA 510(k)
    FDA Class 2 ·Dental

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100073·TEMPORAL SPECULUM SOLID BLADES

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S15014110K0·Tap

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S15014116K0·Tap

    TIBIAL INSERT IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS, INC.·Product code OOG·April 28, 2017

    THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEM: AMISTEM HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 27, 2021

    COBAS 8000 COBAS ISE MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 6, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 7, 2014

    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 26, 2024

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    FDA Recall
    Open, Classified ·Product code KIE·October 9, 2024

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    FDA Adverse Event
    ABBOTT DIABETES CARE INC.·Product code MDS·June 21, 2021

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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