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    PERFECTA PS REVISION STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111448690·ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25

    Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    OXYLOG 3000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 14, 2013

    EASYTRAK 3

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·January 18, 2011

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 28, 2014

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code GAD·December 3, 2024