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

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    Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    Intersurgical Incorporated·05030267140800·22mm Smoothbore breathing system with monitorin...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694041027·3.0mm x 10 Degree ExtremiFuse Implant

    THINFLAP

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036079857·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111111105·DUPLAY DRESSING FCP STR 8"

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112274·SURG-I-BAND WHITE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694070027·ExtremiFuse 3.0mm 10 Degree Implant Sterile Qty 5

    E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION TO HBS HEADLESS BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RELI

    FDA Adverse Event
    Malfunction ·MICSAFE MEDICAL GROUP (CHINA) CO., INC.·Product code GAA·October 14, 2020

    BLUNT TIP SCREW, ÿ 4X46MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·October 28, 2024

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·October 21, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (CRM-KISTA)·Product code NVY·October 30, 2015

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·April 25, 2018

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    Alcon Custom Pak

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