BEUDAMED
    93 results · 21ms · Sources: EU EUDAMED, US FDA

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    RPM RESPIRATORY GATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746108488·DB BKT MINI MS UL LAT 022 T+18 A+6 R=0

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694048972·PrimaLIF 24mm Dilator

    RHEAD

    FDA UDI
    Stryker GmbH·00886385025056·Recon Stem Implant 6mm Collar,Size 3

    ALL SILICONE FOLEY BALLOON CATHETER

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369402606·2way/Translucent 30cc 24fr

    BUN Reagent Kit

    FDA UDI
    MEDICA CORPORATION·00386100001988·Blood Urea Nitrogen Reagent Kit for use with Ea...

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XEN 45 GTS

    FDA Adverse Event
    Injury ·ALLERGAN (IRVINE)·Product code KYF·July 23, 2024

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·April 17, 2024

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 6, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011

    FREEDOM SELF-CATH NELATON CH12

    FDA Adverse Event
    Malfunction ·COLOPLAST MANUFACTURING US, LLC·Product code GBM·August 7, 2008

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 28, 2024

    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

    FDA Recall
    Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

    regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries, Inc. 306·November 30, 2022