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

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    One Step hCG Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Neoloy®

    FDA UDI
    Dentsply International Inc.·D001N1500630·

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486018191·MCK UNI INS TRAY, SIZE 1 CADDY

    Oticon

    FDA UDI
    Oticon A/S·05707131285706·NERA2, RITE 312 WL CBE

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S15006310K0·Tap

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951500630000·Tibial Anchor Tamp

    HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTATE-63 CANCER DIAGNOSTIC TEST

    FDA 510(k)
    FDA Class 1 ·Hematology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    TERMINAL CUP IMPACTOR FOR METAL BACK

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·December 4, 2015

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·May 21, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 5, 2011

    NA

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DQO·August 29, 2008

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026