BEUDAMED
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    STRAUMANN DENTAL ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450308134·

    COLLAGEN NERVE CUFF

    FDA 510(k)
    FDA Class 2 ·Neurology

    DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

    GORE EXCLUDER AAA ENDOPROTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code MIH·May 15, 2013

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·May 3, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 20, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 5, 2011

    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