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

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    HANDHELD ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955746774·SCB APEX 3000ML SINGLE PACK

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006588·1410B 2W NRBV TSHP SM 1/22MM"

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795005345·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493568·

    CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·July 19, 2019

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·May 14, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 10, 2014

    PINN CAN BONE SCREW 6.5MMX40MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·May 19, 2011

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021