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

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    MEDIGROUP CATHETER EXTENDER/REPAIR KIT

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

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00125021·

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320610·CERASMART™ 270 14L Cerec B1 LT 5p Block

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470125021·CERASMART 270 14L CEREC B1 LT 5p

    n/a

    FDA UDI
    Ortho Development Corporation·00822409072538·Blunt Tip Broach Size 2

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694037099·Single Silicone Irrig. Tubing, W&H

    MODEL THERMO TEK QUICKCARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERAM-PRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    CONNECTOR C35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FPA·June 10, 2021

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·March 20, 2013

    ATRIUM ADVANTA V12

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code JCT·August 12, 2014

    SOFTOUCH HEADHUNTER CATHETER

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·March 12, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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