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

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    ROSA Hip System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021260·INTRG WHISP ROTH 1BIC HK-17T 0A 022 LL

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111148316·SKLIT XD STRABIS SCIS STR 4.5"

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180184381·CHUNG T-HANDLE RETRACTOR, SENN STYLE BLADE, 6MM...

    MIRADRY SYSTEM

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

    SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 21, 2023

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·February 22, 2021

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 12, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025