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

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    PERIOPATCH

    FDA 510(k)
    FDA Unclassified ·Unknown

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725536018·Criticare Compatible SpO2 Sensor, 9 Foot Cable ...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws

    AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 9, 2013

    DEPUY DUOFIX MBT TRAY SZ 4

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code NJL·September 23, 2014

    FOXCROSS PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·June 1, 2011

    UNKNOWN LUMBAR IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021