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

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    CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Poly Per-Q-Cath

    FDA UDI
    Bard Access Systems, Inc.·00801741100109·Catheter Placement Kit

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005071·SC 1 lb Pwd Light Red Pink

    DIALY-NATE

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67140005070·SET, Peritoneal Dialysis Set for Neonates

    CAPTURE™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780247739·CAPTURE™ High Torque Screw System The trocar is...

    Capture High Torque Screw System

    FDA UDI
    Smith & Nephew, Inc.·00885556822869·TROCAR

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·December 5, 2024

    MINMED QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·November 21, 2024

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·March 12, 2013

    RPM RESPIRATORY GATING

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS·Product code IYE·February 1, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·February 14, 2008

    1.5MM TI CORTEX SCREW SELF-TAPPING 9MM

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·October 20, 2015

    PREC BRONCH ALL 1.8 115

    FDA Adverse Event
    Malfunction ·MICRO-TECH(NANJING) CO.,LTD·Product code FCL·October 23, 2019

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016