MEDICAL DEVICE

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Brand Owner (click to sort) Address Description
"M" SELECT CooperSurgical, Inc. 95 Corporate Drive Trumbull CT 06611 Medical device, namely, an extraction cup for an obstetrical vacuum delivery kit;
10 SHOOTER SAEED MULTI-BAND LIGATOR COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 medical device, namely, an endoscopic band ligation device;10 and MULTI-BAND LIGATOR;
1072NM Steve Mencanin 25611 Blossom Park Lake Forest CA 92630 Medical device, namely, a handheld device which uses LED light sources for the treatment of cold sores specifically Herpes Simplex Virus HSVI and HSVII;
2 BLUE Dixie USA, Inc. P.O. Box 55549 Houston TX 77255 medical device; namely, patient mover in the nature of a gurney;
A ACTIVE ATHLETE Active Ankle Systems, Inc. 233 QUARTERMASTER CT JEFFERSONVILLE IN 47130 medical device, namely an ankle orthosis;ATHLETE;
A-BRANCH Cook Incorporated 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON IN 47402 Medical device, namely, a synthetic endovascular stent graft;
A-BRANCH COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 Medical device, namely, a synthetic endovascular stent graft;
A-BRANCH COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 Medical device, namely, a synthetic endovascular stent graft;
A-BRANCH COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 Medical device, namely, a synthetic endovascular stent graft;
A-CER MINNTECH CORPORATION 14605 28th Avenue North Minneapolis MN 55447 Medical device, namely, an automated endoscope reprocessor for high-level disinfection of endoscopes;
ABBOTT AIM ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely an intravenous infusion pump;
ABBOTT AIM ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device; namely, an intravenous infusion pump;
ABBOTT AIM ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely an IV infusion pump;The lining is a feature of the mark and does not indicate color.;
ABBOTT AIM AMBULATORY INFUSION MANAGER ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely an intravenous infusion pump;AMBULATORY INFUSION MANAGER;
ABBOTT AIM PLUS ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely, an intravenous pump;The lining is a feature of the mark and does not indicate color.;
ABBOTT GEM ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 MEDICAL DEVICE; NAMELY, AN INFUSION PUMP AND ACCESSORIES FOR DRUG AND NUTRITIONAL DELIVERY;
ABBOTT TDQ ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely a catheter;
ABMS Global Medical Research Suite 202 807 W. Morse Boulevard Winter Park FL 327893726 medical device, namely, an assembled system consisting of a passive urinary control valve with a drainage tube and collection bag which attaches directly to the patient's indwelling catheter to restore normal bladder function;
ACCELERATOR SUTTER CORPORATION 9425 CHESAPEAKE DRIVE SAN DIEGO CA 92123 MEDICAL DEVICE, NAMELY NEUROMUSCULAR STIMULATION PROBE FOR USE IN THE REHABILITATION OF MUSCLES;
ACCLAIM ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park IL 60064 medical device, namely, an infusion pump and accessories for drug and nutritional delivery;
ACCLAIM HOSPIRA, INC. 275 North Field Dr. Lake Forest IL 60045 MEDICAL DEVICE; NAMELY AN INFUSION PUMP AND ACCESSORIES FOR DRUG AND NUTRITIONAL DELIVERY;
ACCLAIM HOSPIRA, INC. 275 North Field Dr. Lake Forest IL 60045 Medical device, namely an infusion pump with accessories, namely infusion sets, for drug and nutritional delivery;
ACCU-SPINA North American Medical Corporation 1649 Sands Place Suite A Atlanta GA 30067 MEDICAL DEVICE, namely, A MECHANICAL ROTATING DECOMPRESSION MACHINE BED USED FOR SPINAL THERAPY USED WITH A MONITORING SYSTEM THAT MONITORS SPINAL RESISTANCE AND ADJUSTS DISTRACTION FORCES;
ACCUTEMP-PROBE KENTEC MEDICAL, INC. 17871 Fitch Avenue Irvine CA 92614 medical device;
ACM STRYKER CORPORATION 2825 Airview Boulevard Kalamazoo MI 49002 Medical device, namely, a bone cement mixing and delivery device;
ACROBAT Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem NC 27105 medical device, namely, a flexible endoscopic injection needle;
ACTISOM Sleep Performance, Inc. 1133 Melville Street Unit #730 Vancouver, BC V6E4E5 Canada Medical device, namely, a device for measuring body position during sleep;
ACTIVAT COBE CARDIOVASCULAR, INC. 14401 West 65th Way Arvada CO 80004 Medical device, namely, a disposable kit consisting primarily of syringes;
ACTIVE ANKLE CRAMER PRODUCTS, INC. 153 West Warren Gardner KS 66030 medical device; namely, an ankle orthosis;ANKLE;
ACTIVE ATHLETE Active Ankle Systems, Inc. 233 QUARTERMASTER CT JEFFERSONVILLE IN 47130 medical device, namely, an ankle orthosis;ATHLETE;
ACUSENSE VOLCANO CORPORATION Suite 500 3721 Valley Centre Drive San Diego CA 92130 medical device, namely, a pressure guide wire;
ADG COLLAGEN CORPORATION 2500 Faber Place Palo Alto CA 94303 medical device, namely needle guides for delivery of collagen treatments;
ADVANCE COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 Medical device, namely, a vascular balloon catheter;
ADVANCED U -SHAPE Shering-Plough HealthCare Products, Inc. 3030 Jackson Avenue Memphis TN 38151 medical device, namely, a footwear insert that relieves pain;
ADVANTAGE MEDIVATORS INC. 14605 28th Avenue Minneapolis MN 55447 Medical device, namely, automated endoscope reprocessor for high-level disinfection of endoscopes;
AERIS NELLCOR PURITAN BENNETT INCORPORATED 675 McDonnell Boulevard, P.O. Box 5840 St. Louis MO 63134 medical device, namely, an oxygen concentrator that provides supplemental oxygen to patients experiencing oxygen insufficiency;
AERO-WRAP Sun Scientific, Inc. c/o Legal Department 145 Palisade Street, Suite LL11 Dobbs Ferry NY 10522 Medical device, namely, a therapeutic inflation compression system comprised primarily of an adjustable therapeutic inflatable compression wrap;
AFECTAIR WINDTREE THERAPEUTICS, INC. 2600 KELLY ROAD SUITE 100 WARRINGTON PA 189763622 Medical device, namely, a device for improving delivery of liquid, powder or aerosolized pharmaceutical preparations and substances, a device for improving delivery of liquid, powder or aerosolized pharmaceutical preparations and substances for treatment of various medical conditions, an adapter for facilitating entrainment of liquid, powder or aerosolized pharmaceutical preparations and substances;
AFECTAIR Discovery Laboratories, Inc 2600 Kelly Road, Suite 100 Warrington PA 18976 Medical device, namely, a device for improving delivery of liquid, powder or aerosolized pharmaceutical preparations and substances, a device for improving delivery of liquid, powder or aerosolized pharmaceutical preparations and substances for treatment of various medical conditions, an adapter for facilitating entrainment of liquid, powder or aerosolized pharmaceutical preparations and substances;
AID CARTRIDGE GUERRERO, RAMON 2522 N. Corinthian Garden Dr #2 Nogales AZ 85621 MEDICAL DEVICE;
AIM HOSPIRA, INC. 275 North Field Dr. Lake Forest IL 60045 Medical device, namely, an intravenous pump;
AIM PLUS HOSPIRA, INC. 275 North Field Dr. Lake Forest IL 60045 Medical device, namely, an intravenous pump;
AIREBAND HEADWEAR 4215 ALDERWOOD LANE CHARLOTTE NC 28215 Medical device, namely headwear for use on a patient to position airway tubes of a positive air pressure device;
AIRWAY ANCHOR Reliable Airway Anchoring Devices 7315 Hix Ct Colleyville TX 76034 Medical device, namely, an airway stabilizing device for use during anesthesia;
ALL-TERRAIN Cook Incorporated 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON IN 47402 medical device, namely, a peripheral transluminal angioplasty balloon;
ALL-TERRAIN BALLOON Cook Incorporated 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON IN 47402 medical device, namely, a peripheral transluminal angioplasty balloon;BALLOON;
ALPHA-PORT MAQUET S.A. Parc de Limère Avenue de la Pomme de Pin F-45160 ARDON France Medical device, used to facilitate mobility, positioning and accessibility of medical fluids; operatory lighting apparatus, namely ceiling lights for medical and surgical equipment;
ALTIUS NEUROS MEDICAL, INC. 26800 Aliso Viejo Parkway, Suite 250 Aliso Viejo CA 92656 Medical device, namely, an implantable neuromodulation device that delivers a high frequency electrical signal for use in chronic pain, motor control, spasticity, and autonomic nervous system applications;
ALTRUS CONMED CORPORATION 11311 Concept Blvd. Largo FL 33773 Medical device, consisting of an energy source and disposable hand piece, for cutting and sealing tissue and vessels during surgery;
ALUMINA 3Gen 31521 Rancho Viejo Rd., #104 San Juan Capistrano CA 92675 Medical device, namely, a battery-powered illuminator with magnification for use in dermatological examinations;
AMICUS CONMED CORPORATION 11311 Concept Blvd. Largo FL 33773 Medical device, consisting of an energy source and disposable hand piece, for cutting and sealing tissue and vessels during surgery;
AMIGO Catheter Robotics, Inc. Suite 275 500 International Drive Budd Lake NJ 078281381 Medical device, namely, a remote manipulation system consisting of a robotic arm, knob, deflection lever, and buttons, to facilitate remote catheterizations;
AMPLIA MEDTRONIC, INC. 710 Medtronic Parkway Minneapolis MN 55432 medical device, namely, a cardiac resynchronization therapy device;
AMPLIA MRI MEDTRONIC, INC. 710 Medtronic Parkway Minneapolis MN 55432 medical device, namely, a cardiac resynchronization therapy device;MRI;
ANDEV CORPORATION Andev Corporation 4114 Wingren Drive Irving TX 75062 Medical device, namely, surgical automaton system for use in anastomosis in the surgical suturing process, which system is comprised of mechanical cart, arm, and mast assembly, surgical wand, applicator kits, operational computer hardware and software, and sterile covers;CORPORATION;
ANDROJOX Shining Buddha Corp. 122 Pitch Irvine CA 92618 Medical device, namely, a lighting device for stimulation of estrogen, progesterone, and testosterone hormones for increasing sexual potency; Medical device, namely, a lighting device for stimulation of serotonin, dopamine, endorphins, oxytocin, estrogen, progesterone, and testosterone hormones for treatment of sexual dysfunction and mood disorders; medical device, namely, a lighting device in the nature of electronic light therapy device for treatment of sexual issues and mood disorders;
ANEUWRAP Ahn, Samuel S. 100 UCLA Medical Plaza Los Angeles CA 900956970 MEDICAL DEVICE, NAMELY A WRAP FOR THE AORTA BEFORE OR AFTER A STENT/GRAFT IS PLACED;
ANGEL Arthrex, Inc. 1370 Creekside Blvd. Naples FL 34108 Medical device, namely a blood centrifuge;Issue New Certificate to: ARTHREX, INC. (DELAWARE CORPORATION) 1370 CREEKSIDE BOULEVARD NAPLES, FLORIDA 34108;
ANGEL CYTOMEDIX ACQUISITION COMPANY 209 Perry Parkway, Suite 7 Gaithersburg, MD 20877 United States Medical device, namely a blood centrifuge;Issue New Certificate to: ARTHREX, INC. (DELAWARE CORPORATION) 1370 CREEKSIDE BOULEVARD NAPLES, FLORIDA 34108;
APLITIP TARO PHARMACEUTICALS U.S.A., INC. 3 Skyline Drive Hawthorne NY 10532 medical device, namely an applicator for the topical administration of pharmaceuticals;
APOLLO TARGET THERAPEUTICS, INC. 47201 Lakeview Boulevard Fremont CA 94537 medical device, namely, detachable balloon for catheter;
APOLLO Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis MN 55369 MEDICAL DEVICE, NAMELY, BIOPSY SEALING DEVICE;
AQUAMEDIC SNAP PRODUCTS, INC. 27 Madison Avenue Clifton NJ 07011 Medical device, namely, thermal hot and cold packs for therapeutic relief;
ARCVITA Richard J. Hawkins 1701 Stamford Lane Austin TX 78703 Medical device, namely, a laser for non-invasive septoplasty;
ARM DEFIBTECH Suite 201 741 Boston Post Road Guilford CT 06437 Medical Device, namely, a device in the nature of a reciprocating ram for mechanically applying CPR;
ART MEDLINE INDUSTRIES, LP Three Lakes Drive Northfield IL 60093 Medical device, namely, device for harvesting autologous skin and tissue from patients;
ARTIX Inari Medical, Inc. 6001 Oak Canyon, Suite 100 Irvine CA 92618 Medical device, namely, mechanical thrombectomy devices for capturing emboli for thrombectomy procedures;
ASEPTISCOPE ASEPTISCOPE, INC. 4061 Stephens St. San Diego CA 92103 Medical device, namely, a dispensing unit for one-time use stethoscope covers;
ASTRAPLUG Vasorum Limited 2012 Orchard Avenue, Citywest Campus Dublin 24 Ireland medical device, namely a wound closure device;
ATB COOK MEDICAL TECHNOLOGIES 750 Daniels Way, P.O. Box 2269 Bloomington IN 47402 medical device, namely, a peripheral transluminal angioplasty balloon;
ATB PEAK Cook Incorporated 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON IN 47402 medical device, namely, a peripheral angioplasty balloon catheter;
ATHENA ADVANCED NEUROMODULATION SYSTEMS, INC. 6901 Preston Road Plano TX 75024 medical device, namely, clinician programmer used to communicate with an implantable pulse generator for deep brain stimulation to treat neurological disorders;
ATLAS ADVANCED NEUROMODULATION SYSTEMS, INC. 6901 Preston Road Plano TX 75024 medical device, namely, clinician programmer used to communicate with an implantable pulse generator for deep brain stimulation to treat neurological disorders;
ATTACHE CATHETER Wholey, Michael H. 19407 Srauss San Antonio TX 78256 Medical device;
AUTHENTIC MEDICAL Authentic Options 4470 Yankee Hill Rd Ste 210 Rocklin CA 95677 Medical device, namely, disposable lead wires for medical diagnosis and treatment purposes for use with ECG/EKG patient monitoring devices; patient monitoring products, namely, electrocardiogram cables and leads for medical diagnosis and treatment purposes and Sp02 probes for use with pulse oximetry to measure blood oxygen saturation for medical diagnosis and treatment purposes; medical devices, namely, clips for connecting lead wires to medical electrodes. Medical, surgical and veterinary apparatus, instruments and devices for use in general surgery; medical, surgical and veterinary apparatus, instruments and devices for use in orthopedic surgery; medical, surgical and veterinary apparatus, instruments and devices for use in urological and gynecological surgery; medical, surgical and veterinary apparatus, instruments and devices for use in abdominal surgery; medical, surgical and veterinary apparatus, instruments and devices for use in vascular and cardiac surgery; medical, surgical and veterinary apparatus, instruments and devices for use in gastro-oesophagal surgery; medical, surgical and veterinary apparatus, instruments and devices for use in anal and colorectal surgery; medical, surgical and veterinary apparatus, instruments and devices for use in plastic and reconstructive surgery; medical and surgical drills for use in soft tissue repair and reconstruction; minimally invasive medical and surgical devices for endovascular diagnosis and therapy of vascular diseases; bone fillers comprising non-living materials;MEDICAL;
AUTOCHILL DJO 5919 Sea Otter Place, Suite #200 Carlsbad CA 92010 medical device; namely, an inflatable, cufflike member having automated means for replenishing chilled fluid for cold compression therapy;
AUTOLOGEL NUO THERAPEUTICS, INC. 207A PERRY PARKWAY, SUITE 1 GAITHERSBURG MD 20877 Medical device, namely, a blood centrifuge;pharmaceutical and veterinary preparation for topical application for use as an aid in wound healing; biological tissue intended for use as a wound covering; wound dressings; burn dressings; surgical dressings; pharmaceutical preparations for wounds; diagnostic reagents for medical and medicinal use; clinical medical reagents; chemical reagents for medical or veterinary purposes; drug testing kits comprised of medical diagnostic reagents and assays for testing body fluids;
AUTOMATIC BLADDER MANAGEMENT SYSTEM Flinchbaugh, Dr. David E. 4855 Big Oaks Lane Orlando FL 32806 Medical device, namely, an assembled system consisting of a passive, pressure-sensing urinary control valve with a drainage tube and collection bag which attaches directly to the patient's indwelling catheter to automatically restore normal cyclic bladder function;
AVANCEN Avancen 19 Moss Point Drive Ormond Beach FL 32174 medical device, namely patient controlled drug delivery system;
AVANT St. Jude Medical One St. Jude Medical Drive St. Paul MN 55117 Medical device, namely, implantable cardioverter defibrillator;
AVANTGARDE TARGET THERAPEUTICS, INC. 47201 Lakeview Boulevard Fremont CA 94537 medical device, namely micro-catheter for vascular applications;
AVICA E.R. SQUIBB & SONS Lawrenceville-Princeton Road Princeton NJ 08540 medical device, namely, a fecal management system comprised of a catheter, an annular balloon, and a pouch, and parts and fittings therefor; ostomy appliances and devices, namely, pouches, flanges, collars, wafers, adhesive rings, filters, skin barriers, and parts and fittings therefor; fecal incontinence devices, namely, drainage containers, pouches, tubing, drainage control adapters and parts and fittings therefor;
AVIGO COVIDIEN LP IP Legal 15 Hampshire Street Mansfield MA 02048 medical device, namely, guidewire;
AVIVO CORVENTIS, INC. Suite 100 2033 Gateway Place San Jose CA 95110 Medical device, namely, electronic device comprising sensors, transmitters, and servers for monitoring vital signs and other physiological parameters and detecting medical events, used as a means of receiving, transmitting, processing, storing and displaying patient medical data;
AVIVO Medtronic Monitoring, Inc. 710 Medtronic Parkway Minneapolis MN 554325604 medical device, namely, a cardiac activity monitor;
AXCESS 21 Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem NC 27105 medical device; namely, a wire guide;21;
AXIS GLAUKOS CORPORATION 229 Avenida Fabricante San Clemente CA 92672 Medical device, namely, ophthalmic surgical blade;
AZURIS CORVENTIS, INC. Suite 100 2033 Gateway Place San Jose CA 95110 Medical device, namely, electronic device comprising sensors, transmitters, and servers for monitoring vital signs and other physiological parameters and detecting medical events, used as a means of receiving, transmitting, processing, storing and displaying patient medical data;
BABY BEAT Medical Equipment Direct, Inc. 5350 Vivian Street Suite C Arvada CO 80002 Medical device, namely, doppler monitor used to listen to fetal heartbeat;
BABY COCOON PRISM ENTERPRISES, L.P. PO Box 680728 San Antonio TX 78268 medical device, namely a device to maintain a newborn baby's internal tempreture consisting of a blanket wrap and internal heating pads.;
BACK BUDDY JAZZERCISE, INC. 2460 Impala Drive Carlsbad CA 92010 medical device, namely, a massage ball, audio tape of exercises, and leaflet describing the exercise for exercise treatment or relief of pain associated with back disorders all contained in a backpack;BACK;
BACK ON TRACK Loft, Aaron J. 919 Bayside Drive, Suite B4 Newport Beach CA 92660 medical device, namely, self administered back adjusting apparatus for back massage;
BACKSAVER CHIROVENTURES, LTD. 900 Commonwealth Place Virginia Beach VA 23464 medical device; namely, a therapeutic exercise device used to strengthen the human back;
BALLOONOTOME Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem NC 27105 medical device, namely a dilating catheter and stone extraction device;
BAM LABS SLEEP NUMBER CORPORATION 1001 Third Avenue South Minneapolis MN 55404 medical device, namely, biofeedback sensors;LABS;
BASIXALPHA MERIT MEDICAL SYSTEMS, INC. 1600 West Merit Parkway South Jordan UT 84095 medical device, namely, inflation device;
BE MOBILE - GO ON THE GO! PREFERRED MEDICAL DEVICES, INC. 6400 Congress Avenue; Suite 2800 Boca Raton FL 33487 Medical device, namely, a urine facilitation device for the incapacitated;
BELS HELPS ADVANCED TECHNOLOGY CONCEPT 2114 Main St Brewster MA 02631 MEDICAL DEVICE, NAMELY ELECTRO MAGNETIC GENERATOR FOR TREATMENT OF DISEASES;
BETA BOOT BETA DERMACEUTICALS, INC. P.O. Box 691106 San Antonio TX 78269 MEDICAL DEVICE, NAMELY, A PLASTIC BOOT USED IN CONJUNCTION WITH LOTION TO SOOTHE AND HEAL SKIN;BOOT;
BFA Paradigm Medical Industries, Inc. 2355 South 1070 West Salt Lake City UT 84119 medical device, namely a device for measuring arterial blood flow in the eye;
 

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Technical Examples
  1. This document describes, among other things, a method of operating a medical device comprising updating a regulatory approval status stored in at least one of the medical device or a second device operable to communicate with the medical device, and enabling or disabling the at least one function in the medical device based on the regulatory approval status. The regulatory approval status corresponds to at least one function performable by the medical device.