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    ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283532·LAHEY FINGER RETRACTOR 4 3/4" 2 PRONG SHARP

    PRIMAFLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    AQUARIUSNET SERVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013

    PORTEX

    FDA Adverse Event
    SMITHS MEDICAL·Product code CAZ·March 16, 2011

    BIOMET SPLINED KNEE STEM

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code JWH·May 20, 2008

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    PECTUS BAR BENDER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HXW·January 15, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012