BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    TECA ELITE DISPOSABLE CONCENTRIC NEEDLES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409076239·Trial Neck 12mm

    ALIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837079871·

    BLUE SKY BIO DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 11, 2024

    BD LUER-LOK¿ TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 10, 2023

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 2, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2014

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·September 30, 2016

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·September 30, 2016

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023