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

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    Repris Bladder Injection System

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

    BALANCE MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304446366·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034203·Profile Zero 25mm Gap Plate

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973106913·TRIAL 90-SRK-180214 POLY PS 2X14MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694065887·Profile 0 25 Gap Plate Sterile Qty 2

    CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIRECTVISION CATHETER, UNCOATED

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

    PHILIPS SONICARE

    FDA Adverse Event
    Injury ·PHILIPS ORAL HEALTHCARE·Product code JEQ·May 14, 2018

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 3, 2022

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    INSTINCT JAVA BLOCKER

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE·Product code NKB·June 13, 2013

    RIGHT ANGLE LINEAR CUTTER, 45MM DLU

    FDA Adverse Event
    Injury ·POWER MEDICAL INTERVENTIONS·Product code GDW·September 29, 2008

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·March 1, 2018

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Surgical Vision Inc·November 21, 2018

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026