BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981179908·Z-Rod, Dia. 6.0mm, Co-Cr, 390mm

    STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SURGIMAX/ SURGIMAX PLUS

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

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 7, 2021

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NIK·October 3, 2014

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 31, 2013

    OMNISPAN MENISCAL FASTENER, 12 DEGREE NEEDLE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MBI·June 27, 2011

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·May 16, 2018

    GALAXY G3 6MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 XSFT 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 4MM X 12CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021

    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025