BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

    FDA 510(k)
    FDA Class 2 ·Immunology

    APEX®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955746798·DCB APEX 1500ML SINGLE PACK

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006601·1410BMPS 2W T MPORT SAL TRAP

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493575·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795003303·

    REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVITA WRIST TYPE BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008

    PINNACLE 300 ACET CUP 50MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 11, 2020

    THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code GWO·April 16, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021