BEUDAMED
    26 results · 21ms · Sources: EU EUDAMED, US FDA

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    YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA

    FDA 510(k)
    FDA Class 1 ·Dental

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092116548·NobelBiocare™ Tri-Lobe-compatible RP Straight M...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130988·NobelBiocare™ Tri-Lobe-compatible RP Straight M...

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964005419·CUSTOM PROCEDURE KIT

    Biomeme DNA/RNA Preservation Buffer (100/pk)

    FDA UDI
    Biomeme, Inc.·00810096640109·Tubes filled with 3mL aliquots of Biomemes DNA/...

    RENEGADE HI-FLO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERIS AMSCO MILLENNIUM STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEEP PRECISION GENERATOR 120VAC

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·June 10, 2024

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·March 12, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 1, 2011

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·February 21, 2008

    ZUMA Z2 7F GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DQY·June 12, 2020

    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

    FDA Enforcement
    Class II ·Ongoing·Acuity Surgical Devices, LLC·June 17, 2020

    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

    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

    FDA Enforcement
    Class II ·Ongoing·Acuity Surgical Devices, LLC·June 17, 2020

    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

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017