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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    KardiaMobile 6L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BCI 3180 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTENDED LIFE BATTERY

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 9, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 11, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 9, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 8, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2024

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·July 24, 2020

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·March 31, 2009

    PROTEGE RX CAROTID

    FDA Adverse Event
    Injury ·EV3 INC.·Product code NIM·November 3, 2008

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011

    UNIFY CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·April 6, 2011

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 17, 2022

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2015

    DEVANEY RT TRIFLANGE SZ24X54

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 21, 2017

    ACCOLADE DR SL MRI (Model L311)

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