BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    PASS LP SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902096273·TPRD LAP 18MM INSTR INNER TRAY

    QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·January 15, 2018

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 2, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 12, 2026

    BLOOD GROUPING REAGENT SOLIDSCREEN II ANTI-D BLEND

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 25, 2011

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Injury ·BD (SUZHOU)·Product code FOZ·December 22, 2017

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    CASH 14 PLAT COIL 4MMX6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    GALAXY G3 MINI 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    Ultrasound Video Gastroscope, Model EG-3670URK, 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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015