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

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    SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bur PM2-70 50K Carb Ø3.1

    FDA UDI
    Bien-Air Surgery SA·07630055502445·

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828135801·GEN4 INTERACTIVE

    COOLEY OCCLUSION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921002680·COOLEY OCCLUSION CLAMP JAW CURVED SHANK

    OPERATING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896046948·OPERATING SCISSORS STRAIGHT SHARP TUNGSTEN CARB...

    COOLEY OCCLUSION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002128·COOLEY OCCLUSION CLAMP JAW CURVED SHANK

    HARDYDISK, AMPICILLIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

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

    REMSTAR AUTO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    ASPHERE M SPEC 12/14 36 +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 8, 2013

    ABBOTT M2000SP

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 16, 2011

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020