BEUDAMED
    27 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bur PM2-70 80K steel Ø4.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055512991·

    Oticon

    FDA UDI
    Oticon A/S·05707131165275·ACPR, ITE VC AT WL L BE ACTO PRO

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001508·Invue Max, Four Level ACP, 89mm

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463228·Bone Chisel Blunt Plastic Handle D 4.0mm WL 120mm

    Klein Surgical

    FDA UDI
    Klein Surgical Systems, Inc.·10850048763286·Endoscopic Bulldog Clamp 60mm

    CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

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

    SYNTHES T-PAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    FDA Adverse Event
    Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    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

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025