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

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    CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

    ADVIA Centaur® LH

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414177236·LH - CENTAUR - RGT - 300 tests

    Vaginal CT/MR Multi Channel Applicator

    FDA UDI
    Nucletron B.V.·08717213052345·Segment Ventral Ø25mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·10884450414559·

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 2, 2015

    IMPLANT, FIXATION DEVICE CONDYLAR PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

    GRAFT DELIVERY SYSTEM MODEL SA-6115

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NURSE'S ASSISTANT O.R. CONTROL SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 16, 2026

    IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 1, 2011

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025

    Video Duodenoscope

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