BEUDAMED
    16 results · 33ms · Sources: EU EUDAMED, US FDA

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    SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776377595·Lateral Wall Retractor, blade length 2 1/2" (64mm)

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213032743·Coupling Treatment Tube for Metal Needles (6)

    DONJOY

    FDA UDI
    DJO, LLC·00888912215824·ICEMAN, INT'L, MODEL 2400

    BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EMERALD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 14, 2013

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·May 13, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    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