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

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    BONE PLATE; BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16711109260·

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 25, 2015

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010036629·LAG SCREW TREPHINE

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 1, 2013

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028713·COPPER NITI 35 BAF 21X25LOSM PK10

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P11092670·11mm PLIF Implant 9mm Wide 26mm Length, 7 deg L...

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916153311·Zeus-P Trial, 11 x 9 x 26mm

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333734·

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024334465·

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911092616·.019 X .025 POSTED SS RIGHT FORM WIRES 26MM (10)

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1671001109260·

    R-SI-LINE METAL-BITE

    FDA 510(k)
    FDA Class 2 ·Dental

    ARROWHEAD FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011

    VERSACARE

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

    ADULT DUAL-HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 18, 2012

    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023