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    NDH MEDICAL, INC.

    FDA registration
    NDH MEDICAL, INC.·3 products·🇺🇸 United States

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    FDA Enforcement
    Class I ·Terminated·H & H Associates·October 9, 2013

    MICRO-TOUCH LATEX MEDICAL GLOVES (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Other ·JOHNSON & JOHNSON MEDICAL, INC. SDN. BDH.·Product code LYY·April 11, 2001

    Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 - Male Luer Cap; 1 - Glass Slide Poly Bag; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides Frosted end; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - CSR Wrap***Catalog Number: CB0370***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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***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***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - #11 Mini Scalpel; 10 - Micro Slides - Frosted end; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Stirring Rod; 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - CSR Wrap ***Catalog Number: BMT1000***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 Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***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 Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 2 - Towel; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0202TL***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 Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 1-1/2" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Stirring Rod; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0187TL***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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 3" x 3" Sponges (4-Ply); 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - CSR Wrap; ***Catalog Number: BMET1104TL***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

    Johner Medical GmbH

    Authorized representative
    🇩🇪 Germany·12 Manufacturers·119 Devices

    Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1601***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 Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 1cc Syringe L/L; 1 - 5cc Syringe L/L; 2 - 10cc Syringe L/L; 1 Needle Safety Foam Block, Large; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4" x 4" Sponges in stacks of 5; 1 - 2"x 3" ADH Dressing; 1 - Towel; 4 Alcohol Swab Sticks; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4 Bone Marrow Needle J Type; 1 - Probe Guide; 1 Obturator.***Catalog Number: CB0318TL***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 Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 Obturator; 1 - Male Luer Cap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x 3" ADH Dressing; 1 - Towel; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0355TL***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***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 -11ga x 4" Bone Marrow Needle "J" Type; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Specimen Label; 1 - Stirring Rod; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 -Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Glass Slide Poly Bag***Catalog Number: BMT1104ATL***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***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 - 21ga x 1-1/2" Safety Needle; 1 - 25ga x 5/8" Safety Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Specimen Label; 5 - 3" x 3" Sponges (4-Ply); 1 - CSR Wrap; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Stirring Rod; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 -Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Towel; 3 - NeedleVISE***Catalog Number: BMT1104STL***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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 2"x3" ADH Dressing; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Obturator; 1 - Male Luer Cap; 1 - Probe Guide; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - CSR Wrap ***Catalog Number: BMET0804TL***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 Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 23ga x 1" Needle; 1 - 18ga x 3-1/2" Needle; 1 - 25ga x 5/8" Needle; 3 - 10cc Syringe L/S; 2 - 1% Lidocaine (5mL); 1 - Male Luer Cap; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 10% Providone Iodine Swab Sticks (3/Pkg.); 3 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 2" x 3" ADH Dressing; 1 - Towel; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 11ga x 4" Bone Marrow Needed "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula***Catalog Number: CB0181TL***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***TLok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 8ga x 4 Bone Marrow Needed J Type; 1 16ga x 2.688 Bone Marrow Needle I Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 - Obturator; 1- Male Luer Cap; 1 T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap***Catalog Number: BMT0804TL***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***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Specimen Label; 1 - Stirring Rod; 1 8ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Glass Slide Poly Bag***Catalog Number: BMT0804ATL***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