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

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    1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649002·INTREPED 06x10 implant

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020248·F3D-Z CIF 13mmx15mmx10mm -6 deg

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106100·Trial, 26 x 10mm, 8 Degree, Tapered, Straight

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·July 20, 2012

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100100·Tray Insert

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K1100100·Tray Insert

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100100·Tray Insert 3, Cosmolock, Arcamed

    LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

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

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 14, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 23, 2014

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·June 1, 2011

    UNKNOWN LUMBAR IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·September 17, 2019

    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

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

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