BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    QUART ARTERIAL FILTER, MODEL HBF 140

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    HQV 51100#ADULT PRE-CONNECTED PACK

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTM·February 23, 2015

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104354·Biomet 3i Certain®-compatible 4.1mm 30° Multi-U...

    ComfyRay Size 1 WHITE Holders 2-Pack + Two "G" Rings and Rods

    FDA UDI
    CLIKTECH LLC·00856200001787·ComfyRay Size 1 WHITE Holders 2-Pack + Two "G...

    PET SHIPPING SYSTEM

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175001776·Cabinet, Pet, Unit Dose, 0.25" Lead (accommodat...

    PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

    FDA 510(k)
    FDA Class 2 ·General Hospital

    S-ROM*CUP ACE,ZTT,PD-2,46MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 13, 2013

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 25, 2011

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·February 19, 2008

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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