BEUDAMED
    66 results · 31ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AXS

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327358452·BONE SCREW, AXS, SELF-TAPPING

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193109169·HA PEEK EVOS Straight, ,12mmx8mmx 22mm , FLAT 5...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540365027·Bone Screws, Cross-Pin, self-tapping

    BD LUER-LOK¿ TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 4, 2022

    DIGITAL RADIOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECG HOME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·October 3, 2013

    FEMORAL IMPACTOR HEAD/TIBIAL IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS·Product code LXH·May 1, 2013

    EXPRESS CURETTE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC.·Product code HTF·June 2, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·August 12, 2008

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·September 27, 2013

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·September 27, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

    FDA Recall
    Terminated ·Breg Inc·Product code ILO·January 14, 2013

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·February 13, 2013

    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·February 20, 2013

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    FDA Recall
    Terminated ·Breg Inc·Product code ILO·January 14, 2013

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·February 20, 2013

    RECEIVED ONE METER SN 53533070744, ONE VIAL OF STRIP LOT# 303401 EXP. 11-2012 WI

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2012