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    KX MEDICAL, INC.

    FDA registration
    KX MEDICAL, INC.·2 products·🇺🇸 United States

    AR Experts B.V.

    Authorized representative
    🇳🇱 Netherlands·65 Manufacturers·3355 Devices

    TOP Medical B.V.

    Importer
    🇳🇱 Netherlands·6 Manufacturers

    VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code KRZ·October 25, 2011

    Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·August 1, 2008

    AXIOM ARISTOS FX

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. CX-RU US QT·Product code KPR·July 8, 2014

    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; CD-ROM - Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water Whole Blood Primer, 6 x 1 mL Sample Vials, 2 x 100 Instruction Manual. Bio-Rad Laboratories Inc. Hercules, CA 94547 Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·July 28, 2011

    Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code DQO·June 9, 2011

    Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 1 - Ruler; 2 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 -1% Lidocaine (5mL); 1 - CSR Wrap***Catalog Number: CG0305***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 4 - Towel; 1 - Ruler; 1 - 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 2% Lidocaine (10mL) ; 1 - CSR Wrap***Catalog Number: CG0287***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -21ga x 1-1/2 Needle; 1 - 25ga x 5/8 Needle; 1 - 19ga x 1-1/2 Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 1% Lidocaine (5mL); 1 - Specimen Label; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 3 x 3 Sponges in stacks of 5 (4-Ply); 1 - x 3 Bandage; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0236***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 - CSR Wrap 48" x 48"; 1 - Fenestrated Drape; 4 -10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Chloraprep Applicator (3ml); 2 - 2% Lidocaine (10mL); 2 - Towel; 1 - " x 3" Bandage; 1 - Needle Safety Foam Block, Large; 6 - Specimen Label; 1 - Scalpel #11; 1 - 25ga x 5/8" Needle w/ Safety Glide; 1 - 21ga x 1-1/2" Needle w/ Safety Glide; 1 - 5 Curved Hemostat; 2 - 4" x 4" Sponges in stacks of 5; 1 -19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - Ruler with Protractor***Catalog Number: CG00548***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement

    FDA Recall
    Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement

    FDA Recall
    Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026. Tricompartmental Knee Replacement

    FDA Recall
    Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. Tricompartmental Knee Replacement

    FDA Recall
    Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement

    FDA Recall
    Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013