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

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    OsteoCentric Bone Plate and Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721377·Hartman-Herzfeld Cup-Shape Forceps 3" (7.5cm) s...

    URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

    FDA 510(k)
    FDA Unclassified ·Unknown

    BACKSTOP AND BACKSTOP INJECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 7, 2022

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 28, 2019

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·June 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 25, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·June 26, 2019

    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

    FDA Enforcement
    Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018