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

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    DIRECTVISION CATHETER, UNCOATED

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

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158212954·PROBE BUTTONED WITH EYE 2MMØ 5.75"

    Humelock II Cementless Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037301081·HUMELOCK II STEM TA6V SIZE 14 CEMENTLESS TI/HA

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00190376115993·14mm SACRAL PLATE, TF

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037309254·SUPERO LATERAL SYMETRIC GLENOID K-WIRE GUIDE + ...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100140·Implant Tray

    CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIRSTSAVE BIPHASIC MODEL #9200 AND 9210

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OT VERIO FLEX METER

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

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·May 13, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 10, 2014

    ACCU-CHEK RAPID D INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·May 20, 2011

    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

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025