BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    BRIGHTMATTER PLANNING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125298·20-30 MV FOR MEN CLSC CALF STD NAVY VII

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925015272·MCGEE PISTON 4.00 MM LENGTH .5 MM DIAMETER PLAT...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720783·Bengolea Forceps 10-1/4" (25.6cm), straight

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197053693·Baby-Mixter Dissect.and Ligature Forceps curved...

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PN RELION 31G X 6MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·July 28, 2021

    PN RELION 31G X 6MM 3B TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·May 24, 2021

    PN RELION 31G X 6MM 3B TW

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·April 28, 2021

    PN RELION 31G X 6MM 3B TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·June 29, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

    D-M 2.0MM BEADED CABLE SET SS

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDQ·May 31, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 15, 2011

    PN RELION 31G X 6MM 3B TW 50CT

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·April 2, 2021

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019