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

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    VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 26, 2024

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IE-ZEN (IN CLEAR SERIES HEARING AID)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    CAPTURA HOT BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011

    CENTRA 850 BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 12, 2008

    BIOSENE WEBSTER NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC.·Product code OAD·July 24, 2006

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    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