BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    Antimicrobial Silicone PHMB Foam Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258637150·

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010148·Pinnacle .022 MC LR3 HK -6T 3A 0O (10PK)

    Marquis

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730012548·Marquis MBT 022 LR3 Hk Rx -6 Tor +3 Ang (10PK)

    Sensation

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730003133·Sensation MBT 022 LR3 Hk Rx 0° Tor. +3° Ang.(10PK)

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167310223310110·

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707112097·Pinnacle .022 MC LR3 HK -6T 3A 0O (10PK) PINNACLE

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707114008·Votion .022 MC LR3 HK -6T 3A 0O (10PK) VOTION

    Sensation M

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730011466·Sensation M MBT 022 LR3 Hk Rx 0° Tor. +3° Ang. ...

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016661·ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offse...

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008312·Votion .022 MC LR3 HK -6T 3A 0O (10PK)

    SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

    TRIMA ACCEL PLT, PLS GERMAN SET

    FDA Adverse Event
    Malfunction ·CARIDIAN BCT·Product code LKN·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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