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

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    PHILIPS INTEGRIS ALLURA

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040060879·CSR Wrap 36"x36"

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040007501·CSR Wrap 36"x36"

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950023820·NEEDLEHOLDER CRILEWOOD CURVED 6" 15CM

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002016·artVeneer life upper posteriors, S, A2

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105437·HA PEEK EVOS Straight, ,16mmx8mmx 30mm , FLAT ...

    Vista

    FDA UDI
    Modus Medical Devices Inc·G34310020160·Vista-16 Cone Beam Optical CT Scanner

    STRONGBACK

    FDA UDI
    STRONGBACK MOBILITY USA, LLC·07640176290169·Transport wheelchair, Seat width: 18''/45 cm, R...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188584·Battalion, LLIF Trial, 0°, 20 mm Wide, 16 mm X ...

    BARCOMED 5MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    PSK ENDOSCOPE CLEANING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 2, 2022

    DOUBLE LUMEN BREAST IMPLANT, 400 CC

    FDA Adverse Event
    Injury ·MCGHAN MEDICAL CORP.·Product code FTR·May 17, 1994

    NIM® EMG

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·March 13, 2017

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 13, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 27, 2011

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GAG·February 22, 2008

    Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.

    FDA Recall
    Terminated ·Johnson & Johnson Vision Care, Inc.·Product code MVN·December 1, 2011

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·September 4, 2013

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020