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

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    MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

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

    InnoSpire Essence

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730001937·Innospire Essence 120V 60HZ (1102058) EU, 6-pack

    GUS

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436113038·G32-E Gus countertop station

    Tibial Keel Punch 5-6

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056643·

    IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT

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

    DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 10, 2022

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·February 18, 2025

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 19, 2014

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·February 7, 2025

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Injury ·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024