BEUDAMED
    24 results · 22ms · 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 ×

    BIOSCANNER TRIGLYCERIDES TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964004924·CUSTOM PROCEDURE KIT

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054441·Polycarbonate Crowns

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092116593·NobelBiocare™ Tri-Lobe-compatible RP 30° Multi-...

    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023

    PenEvac1

    FDA UDI
    I.C. MEDICAL, INC.·00817688022749·PenEvac1®, Stainless Steel Blade, 10’ Tube, 22 ...

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 2, 2024

    DATEX-OHMEDA INOVENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WILSON-COOK REUSABLE HOT BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEA·March 12, 2013

    REPAIR NEPTUNE ROVER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·February 1, 2011

    CCO CATHETER INTERFACE CABLE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·February 18, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·February 22, 2017

    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

    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