BEUDAMED
    20 results · 22ms · 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.
    Filters Regulation: Us FDA ×

    PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100554·LIEBERMAN SPECULUM SOLID LARGE

    CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    2124215-2011-07627

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVY·July 7, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 14, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 19, 2020

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024