BEUDAMED
    27 results · 21ms · 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 ×

    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

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

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741105173·Catheter Placement Kit

    DIALY-NATE

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67140005370·SET W/ LUER LOCKING CONNECTIONS, W/ UNBONDED TU...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099587·MAX 1ST MOLAR RIGHT 92 BANDS

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0005371·CC/ Dentine D-B2

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782021347·CC/ Dentine D-B2

    System Drape

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436108628·Sterile polyethylene instrument drape for use w...

    GeneXpert Infinity-48s System

    FDA UDI
    CEPHEID·07332940004347·

    MONOFILAMENT BIOSYN SUTURE

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

    ENHANCED COMPENSATING FILTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIOSAVE HYBRID, 3.1 EDITION

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·February 5, 2025

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·March 12, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 24, 2011

    COOL-TIP RF SINGLE, 15 CMX 3 C

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·February 11, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024