BEUDAMED
    9 results · 23ms · 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 ×

    Raptor Aspiration Catheter; Balt Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Provisio™ SLT IVUS™ System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OxyMinder

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 11, 2014

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC·Product code NBW·November 25, 2008

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 23, 2013

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 7, 2023

    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·May 7, 2014