BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)

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

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613019693·Stellbrink (Syvonectomy) Bone Rongeur, Half Cur...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361010777·PedFuse Reset, SLD, 7.0mm x 65mm

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659173712·6.5 Cancellous Bone Shaft Screw, hex, _x000D_...

    6.5 Cancellous Bone Shaft Screw, hex, St.Steel, L 65/32 mm

    FDA UDI
    mahe medical gmbh·EMAH00100110650·6.5 Cancellous Bone Shaft Screw, hex, St.Ste...

    CitreLock 6.5mm Reamer

    FDA UDI
    Acuitive Technologies, Inc.·00810027270078·

    iASSIST® Knee System

    FDA UDI
    Orthosoft Inc·00887868519161·

    iASSIST

    FDA UDI
    Orthosoft Inc·00889024305496·

    DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CRANIAL STEREOTACTIC EQUIPMENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 15, 2025

    CMD 20-1060 GLENOID PSI

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code LXH·February 1, 2021

    COULTER® LH500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 19, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 8, 2011

    ISOFLEX P

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    CARPAL POLY MEDIUM- STD.

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code JWJ·September 17, 2015

    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover, Optima CT540 Gantry Top Asm with Rating Plate,SGB tube and CJ cover for Hino, OPTIMA CT540 TANG, OPTIMA CT540 TANG BEIJING, OPTIMA CT540 TANG HINO

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021