BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    CHESAPEAKE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198505·AK3 Ultra Insert Trial Size 2, 11mm

    EFILM WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    DOUBLE MOBILITY LINER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 3, 2013

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 20, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

    MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2023

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022