BEUDAMED
    16 results · 21ms · 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 ×

    ORTHOGENESIS LPS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022256·The ENDO CARRY-ON Procedure Kit contains all of...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114094·SIMCOE CORTEX EXTRACTOR 23GA 0.4MM PK/10

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002867·Jacobson Micro Needle Holder Round Handle

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 29, 2024

    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK TOBRAMYCIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 29, 2024

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 22, 2011

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 22, 2023

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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