BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    cobas Cdiff Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508512·LISTER BANDAGE SCISSORS 8"

    LACTOSORB* 1.5MM SYSTEM TEMPLATE

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036066437·

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249288·PrimePadPlus-K14-3422

    SPACELABS MEDICAL PATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D3 CHROMA

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·August 3, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 5, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 28, 2011

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-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

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016