BEUDAMED
    28 results · 24ms · Sources: EU EUDAMED, US FDA

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    G-FORCE TI SUTURE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INDIA SHARPENING STONE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048157·INDIA SHARPENING STONE MEDIUM 105-115mm X 40-45...

    BREG

    FDA UDI
    BREG, INC.·00672736134016·1 Ice Water Container, 1 12 VDC output and 240 ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450412770·

    HS Stand. Burr, Ø3.1x95, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507201·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450448236·

    Tibial Trial UC Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042998·

    REMSTAR AUTO A-FLEX

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

    STEM: SMS SOLID STEM STD SIZE 10

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 20, 2022

    TEMPO AQUA ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STENT SUPPORT GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASSIST RAIL CS SERIES 9153650456

    FDA Adverse Event
    Malfunction ·FLEXTRONICS·Product code FNL·September 24, 2015

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    NEXGEN ZIMMER MIS TM TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·May 17, 2011

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    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

    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