BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 3, 2023

    LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOCONTROL PELVIC FLOOR THERAPY SYSTEM

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

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 22, 2013

    EXPRESS 4

    FDA Adverse Event
    Malfunction ·IRIS DIAGNOSTICS·Product code JQC·August 12, 2014

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 28, 2011

    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

    CryoValve Allograft, Heart valve.

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·February 24, 2003

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012