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    PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HQF·February 3, 2014

    Aztec

    FDA UDI
    Aztecmed/Ent LLC·B87111300100·Rhinus Blakesley Forcep upturn

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002967·15mm 5 Hole Y Plate

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113005·HA PEEK EVOS Straight, ,10mmx10mmx 30mm , FLAT ...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946011635·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946014827·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946059576·X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LD, NIBP,...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946018535·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)

    1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    HDL CHOLESTEROL (HDLX) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ATAC PAK MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Vega Endocardial Pacing Leads

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Vega Endocardial Pacing Leads

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·July 23, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 1, 2024