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

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    KODAK EKTASPEED DENTAL X-RAY FILM

    FDA 510(k)
    FDA Class 1 ·Radiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119257·

    SPOTCHECK

    FDA UDI
    ASTORIA-PACIFIC, INC.·00725609000458·Negative Control Card

    LBI EMBOLECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CAPTIVATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FDI·May 23, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TOP END·Product code IOR·May 8, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012

    1200SX, 600SE, PQ/IQ CT SCANNERS

    FDA Adverse Event
    Other ·PHILIPS MEDICAL BOTHELL WA·Product code JAK·August 9, 2010

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code FWX·May 21, 2008

    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAN·May 10, 2024

    VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code NEW·May 10, 2024

    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015