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

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    ARROW Short Stem Humeral System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707060987·BRACKETS 22 ANT

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112472·BARRON VACUUM TREPHINE 7.0MM

    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 29, 2022

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 4, 2015

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·August 11, 2011

    AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·June 27, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 10, 2022

    UNK_SUCTION COAGULATOR

    FDA Adverse Event
    Injury ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·December 12, 2024

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components

    FDA Recall
    Open, Classified ·InfuTronix LLC·Product code FRN·February 21, 2024

    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components

    FDA Recall
    Open, Classified ·InfuTronix LLC·Product code FRN·February 21, 2024

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Baxter Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·March 20, 2024

    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

    FDA Recall
    Open, Classified ·Aerin Medical, Inc.·Product code GEI·November 12, 2024