DeviceEstablishmentPulse: all 1,000 record reports, page 5 of 5

Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 801 to 1,000: Isomedix Operations Inc. (contract sterilizer, Chester, NY): 3 new FDA device listings, incl. dressing, wound, drug to Coba Biomedical PTY (Ltd) (contract manufacturer, Bloemfontein Free State, ZA): 27 new FDA device listings, incl. hook, ophthalmic. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

New York

• Isomedix Operations Inc. (contract sterilizer, Chester, NY): 3 new FDA device listings, incl. dressing, wound, drug
• Metropolis International, LLC (repackager or relabeler, Long Island City, NY): 2 new FDA device listings, incl. system, x-ray, tomography, computed
• Microstructure Imaging, Inc (specification developer, Brooklyn, NY): 2 new FDA device listings, incl. system, image processing, radiological
• Pathwai, Inc (manufacturer, New York, NY): 6 new FDA device listings, incl. pulmonary hypertension machine learning-based notification software
• Praxis Powder Technology, Inc. (contract manufacturer, Queensbury, NY): 5 new FDA device listings, incl. cerclage, fixation
• Premium Plus Dental Supplies Inc (other, Brooklyn, NY): 12 new FDA device listings, incl. material, impression
• Radformation, Inc. (manufacturer, New York, NY): 3 new FDA device listings, incl. radiological image processing software for radiation therapy
• Safetec Of America, Inc. (manufacturer, Buffalo, NY): 6 new FDA device listings, incl. cement, stomal appliance, ostomy
• Secured Ortho Manufacturing Of America, LLC (specification developer, Deer Park, NY): 2 new FDA device listings, incl. sleeve, limb, compressible
• Siemens Healthcare Diagnostics Inc. (specification developer, Tarrytown, NY): 9 new FDA device listings, incl. colorimetry, acetaminophen
• Skil-Care Corp. (contract manufacturer, New Rochelle, NY): 4 new FDA device listings, incl. adaptor, dressing
• Sterigenics U.S., LLC (contract sterilizer, Queensbury, NY): 68 new FDA device listings, incl. electrode, cortical
• Sxwell USA LLC (specification developer, New York, NY): 4 new FDA device listings, incl. lubricant, personal

North Carolina

• Acme United Corp. (repackager or relabeler, Rocky Mount, NC): 2 new FDA device listings, incl. dressing, wound, occlusive
• Emage Medical, LLC (other, Charlotte, NC): 5 new FDA device listings, incl. massager, therapeutic, electric
• Holger Bumueller LLC (contract manufacturer, Rutherfordton, NC): 3 new FDA device listings, incl. dilator, lachrymal
• Konica Minolta Healthcare Americas, Inc (manufacturer, Garner, NC): 2 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager)
• Lightning X Products, Inc (manufacturer, Charlotte, NC): 32 new FDA device listings, incl. airway, oropharyngeal, anesthesiology
• Mdd Options, LLC (other, New Hill, NC): 3 new FDA device listings, incl. spinner, slide, automated
• Medical Action Industries, Inc. 306 (manufacturer, Arden, NC): 4 new FDA device listings, incl. medical glove, specialty
• Pulmera Inc. (specification developer, Charlotte, NC): 2 new FDA device listings, incl. system, x-ray, tomography, computed
• restor3d, inc. (manufacturer, Durham, NC): 4 new FDA device listings, incl. shoulder prosthesis, reverse configuration
• Salvin Dental Specialties, LLC (repackager or relabeler, Charlotte, NC): 3 new FDA device listings, incl. bone grafting material, animal source
• Sterigenics U.S., LLC (contract sterilizer, Charlotte, NC): 15 new FDA device listings, incl. radioimmunoassay, thyroid-stimulating hormone
• Sterigenics US LLC (contract sterilizer, Charlotte, NC): 16 new FDA device listings, incl. rod, fixation, intramedullary and accessories
• Structure Medical, LLC. (contract manufacturer, Mooresville, NC): 7 new FDA device listings, incl. appliance, fixation, spinal intervertebral body
• Teleflex Medical LLC (specification developer, Morrisville, NC): 4 new FDA device listings, incl. suture, surgical, absorbable, polydioxanone
• Ulthera Inc (specification developer, Raleigh, NC): 2 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic

Ohio

• Aps Materials, Inc. (contract manufacturer, Dayton, OH): 12 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented
• Guardian Medical USA, Inc (contract manufacturer, Swanton, OH): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Hammill Mfg. Co. (contract manufacturer, Maumee, OH): 4 new FDA device listings, incl. appliance, fixation, spinal intervertebral body
• Health Care Logistics, Inc. (repackager or relabeler, Urbancrest, OH): 5 new FDA device listings, incl. set, administration, intravascular
• Huneo, LLC (manufacturer, Willoughby Hills, OH): 3 new FDA device listings, incl. automatic event detection software for polysomnograph with electroence
• Neoconcepts LLC (other, Lewis Center, OH): 3 new FDA device listings, incl. low power electrosurgical devices for skin lesion destruction
• Sterigenics US, LLC (contract sterilizer, Lewis Center, OH): 38 new FDA device listings, incl. injector and syringe, angiographic
• True Indicating LLC (manufacturer, Toledo, OH): 2 new FDA device listings, incl. biological sterilization indicator with indirect growth detection

Oklahoma

• Smith & Nephew Inc. (manufacturer, Oklahoma City, OK): 3 new FDA device listings, incl. intra-articular orthopedic stereotaxic navigation instrument

Oregon

• Orchid Orthopedic Solutions Oregon, Inc. (contract manufacturer, Oregon City, OR): 3 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol
• Ortho-Med, Inc. (repackager or relabeler, Tigard, OR): 6 new FDA device listings, incl. tray, surgical, instrument

Pennsylvania

• Aesculap, Inc. (other, Center Valley, PA): 2 new FDA device listings, incl. shunt, central nervous system and components
• Alta Smiles, LLC (manufacturer, Fort Washington, PA): 13 new FDA device listings, incl. instrument, ligature tucking, orthodontic
• Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components (contract manufacturer, Huntingdon Valley, PA): 20 new FDA device listings, incl. thoracolumbosacral pedicle screw system
• B. Braun Medical Inc. (other, Allentown, PA): 2 new FDA device listings, incl. system, irrigation, urological
• Bechtel Medical Inc (manufacturer, Phoenixville, PA): 2 new FDA device listings, incl. dressing, wound, occlusive
• Centinel Spine, LLC (specification developer, West Chester, PA): 2 new FDA device listings, incl. manual instruments designed for use with total disc replacement device
• Choicemmed America Corporation (repackager or relabeler, Bristol, PA): 3 new FDA device listings, incl. bottle, collection, vacuum
• Fruh Packaging Inc. (contract manufacturer, Exton, PA): 2 new FDA device listings, incl. plate, fixation, bone
• Globus Medical, Inc. (manufacturer, Audubon, PA): 16 new FDA device listings, incl. thoracolumbosacral pedicle screw system
• HR PHARMACEUTICALS, INC d/b/a HR HealthCare (manufacturer, York, PA): 4 new FDA device listings, incl. collector, urine, powered, non indwelling catheter
• NuVasive Specialized Orthopedics, Inc. (manufacturer, Audubon, PA): 2 new FDA device listings, incl. rod, fixation, intramedullary and accessories
• Philips Ultrasound LLC (contract manufacturer, Reedsville, PA): 32 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Septodont, Inc (specification developer, Lancaster, PA): 2 new FDA device listings, incl. device, electrical dental anesthesia
• Sound Technology Inc. (manufacturer, State College, PA): 4 new FDA device listings, incl. automated radiological image processing software
• Synthes (USA) Products LLC (specification developer, West Chester, PA): 5 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable
• Tela Bio, Inc. (manufacturer, Malvern, PA): 2 new FDA device listings, incl. mesh, surgical, polymeric
• Trend Medical, LLC (specification developer, Bethlehem, PA): 4 new FDA device listings, incl. splint, hand, and components
• X-Nav Technologies, LLC. (manufacturer, Lansdale, PA): 2 new FDA device listings, incl. dental navigation system

PH

• Philipcare Medical Manufacturing Inc. (contract manufacturer, Lipa Batangas, PH): 2 new FDA device listings, incl. mattress, flotation therapy, non-powered

PK

• Acheron Instruments (Pvt.) Ltd. (manufacturer, LAHORE Punjab, PK): 134 new FDA device listings, incl. laryngoscope, non-rigid
• Acme Commercial Ways Ltd. (manufacturer, Sialkot Punjab, PK): 4 new FDA device listings, incl. syringe, cartridge
• Densol International (Private) Limited (manufacturer, Sialkot Punjab, PK): 35 new FDA device listings, incl. mirror, mouth
• Garana Industries Private Limited (contract manufacturer, SIALKOT Punjab, PK): 4 new FDA device listings, incl. instrument, cast application/removal, manual
• Hexamed Pvt Ltd (contract manufacturer, Sialkot Punjab, PK): 59 new FDA device listings, incl. scissors, nasal
• Madhi Corporation (manufacturer, Sialkot Punjab, PK): 3 new FDA device listings, incl. curette, surgical, general use
• Medcave Private Limited (manufacturer, Sialkot Punjab, PK): 100 new FDA device listings, incl. wrench
• Myka Sons & Co (manufacturer, Sialkot Punjab, PK): 2 new FDA device listings, incl. mirror, mouth
• Surgicon Pvt Ltd (contract manufacturer, Sialkot Punjab, PK): 9 new FDA device listings, incl. hook, microsurgical ear

Puerto Rico

• Bard Shannon Limited (contract manufacturer, Humacao, PR): 3 new FDA device listings, incl. mesh, surgical, polymeric
• Ethicon, LLC (manufacturer, Guaynabo, PR): 3 new FDA device listings, incl. suture, surgical, absorbable, polydioxanone
• Medtronic Puerto Rico Operations Co., Humacao (manufacturer, Humacao, PR): 3 new FDA device listings, incl. appliance, fixation, spinal interlaminal
• Steris Isomedix Puerto Rico, Inc. (contract sterilizer, Alts De Cerro Gordo 3&4, PR): 3 new FDA device listings, incl. thoracolumbosacral pedicle screw system
• Stryker Puerto Rico, LLC. (contract manufacturer, Arroyo, PR): 4 new FDA device listings, incl. nasopharyngoscope (flexible or rigid)

Rhode Island

• Boston Scientific Corporation (manufacturer, Coventry, RI): 10 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)
• Davol Inc., Sub. C.R. Bard, Inc. (specification developer, Warwick, RI): 3 new FDA device listings, incl. mesh, surgical, polymeric
• Emblation Inc. (other, Lincoln, RI): 3 new FDA device listings, incl. system, ablation, microwave and accessories

SG

• Beyonics International PTE. Ltd. (contract manufacturer, SINGAPORE North West, SG): 5 new FDA device listings, incl. stimulator, nerve
• Cmt Health PTE. Ltd. (specification developer, Singapore, SG): 9 new FDA device listings, incl. needle, hypodermic, single lumen
• Jabil Circuit (Singapore) Pte Ltd (contract manufacturer, Singapore Central Singapore, SG): 4 new FDA device listings, incl. reduced- montage standard electroencephalograph
• Steris Tomoe Singapore PTE Ltd (contract sterilizer, Singapore South West, SG): 10 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid
• Uan Prime PTE. Ltd. (foreign exporter, singapora, SG): 40 new FDA device listings, incl. cushion, wheelchair

South Carolina

• Arthrex Manufacturing Inc. (contract manufacturer, Pendleton, SC): 7 new FDA device listings, incl. fastener, fixation, biodegradable, soft tissue
• Isomedix Operations Inc. (contract sterilizer, Spartanburg, SC): 8 new FDA device listings, incl. drills, burrs, trephines & accessories (manual)
• North American Rescue, LLC. (manufacturer, Greer, SC): 5 new FDA device listings, incl. burn kit without drug

South Dakota

• Spartronics Watertown LLC (contract manufacturer, Watertown, SD): 6 new FDA device listings, incl. stimulator, spinal-cord, totally implanted for pain relief

Tennessee

• Alphatec Spine, Inc. (manufacturer, Memphis, TN): 10 new FDA device listings, incl. system, image processing, radiological
• Daxor Corporation (manufacturer, Oak Ridge, TN): 2 new FDA device listings, incl. container, specimen, non-sterile
• Dt Medtech LLC (specification developer, McMinnville, TN): 11 new FDA device listings, incl. gauge, depth
• Elite Medical, LLC (contract manufacturer, Bartlett, TN): 17 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• Elite Medical, LLC (contract manufacturer, Cordova, TN): 2 new FDA device listings, incl. spinal vertebral body replacement device
• Engineered Medical Systems, LLC (contract manufacturer, Bartlett, TN): 29 new FDA device listings, incl. spinal vertebral body replacement device
• Globus Medical, Inc. (manufacturer, Memphis, TN): 12 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, uncemented
• Medical Buyers Group, LLC (repackager or relabeler, Brentwood, TN): 2 new FDA device listings, incl. system, blood collection, vacuum-assisted, manual
• Medtronic Sofamor Danek USA, Inc. (specification developer, Memphis, TN): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Mr. Christmas LLC (other, Memphis, TN): 5 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Plastic Electromechanic Company Medical Device (manufacturer, Bir Mcherga Zaghouan, TN): 2 new FDA device listings, incl. spirometer, therapeutic (incentive)
• Smith & Nephew, Inc. (manufacturer, Memphis, TN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol
• Smith & Nephew, Inc. (manufacturer, Memphis, TN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol
• Vilex LLC (manufacturer, Mcminnville, TN): 9 new FDA device listings, incl. starter, bone screw
• Wright Medical Technology, Inc. (manufacturer, Arlington, TN): 5 new FDA device listings, incl. filler, bone void, calcium compound
• Wright Medical Technology, Inc. (specification developer, Arlington, TN): 5 new FDA device listings, incl. filler, bone void, calcium compound

Texas

• Eminent Spine, LLC (manufacturer, Plano, TX): 2 new FDA device listings, incl. thoracolumbosacral pedicle screw system
• Fx Shoulder Solutions Inc. (specification developer, Addison, TX): 4 new FDA device listings, incl. shoulder prosthesis, reverse configuration
• Gramercy Extremity Orthopedics, LLC. (manufacturer, Richardson, TX): 9 new FDA device listings, incl. countersink
• Healgen Scientific LLC (specification developer, Houston, TX): 3 new FDA device listings, incl. kit, direct antigen, negative control
• Inspiration Medical Technology, Inc. (repackager or relabeler, Carrollton, TX): 5 new FDA device listings, incl. dressing, wound, hydrophilic
• Maestro Logistics, LLC (contract manufacturer, Austin, TX): 2 new FDA device listings, incl. washer, bolt nut
• Mastercraft Dental Co. Of Texas (manufacturer, Midlothian, TX): 4 new FDA device listings, incl. chair, with casters
• Maxter Healthcare Inc (manufacturer, Rosharon, TX): 4 new FDA device listings, incl. fentanyl and other opioid protection glove
• Midwest Sterilization Corp. (contract sterilizer, Laredo, TX): 13 new FDA device listings, incl. catheter, percutaneous
• Mlife Diagnostics LLC (contract manufacturer, Marshall, TX): 11 new FDA device listings, incl. test, methamphetamine, over the counter
• Rapid Medical Inc. (other, Southlake, TX): 4 new FDA device listings, incl. catheter, thrombus retriever
• Sterigenics US LLC (contract sterilizer, Fort Worth, TX): 58 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Sterigenics US LLC (contract sterilizer, Grand Prairie, TX): 15 new FDA device listings, incl. tape and bandage, adhesive
• Swiss-American CDMO,LLC (contract manufacturer, Carrollton, TX): 4 new FDA device listings, incl. dressing, wound, drug
• Van Sickle Surgical Instruments, Inc. (repackager or relabeler, Hurst, TX): 3 new FDA device listings, incl. saw, nasal
• Viant San Antonio, Inc. (contract manufacturer, San Antonio, TX): 4 new FDA device listings, incl. temporarily implanted peripheral nerve stimulation system for sustaine

TH

• Avita Corp (Thailand) Co., Ltd. (manufacturer, Chonburi Chon Buri, TH): 5 new FDA device listings, incl. pad, heating, powered
• Epic International (Thailand) Co., Ltd. (manufacturer, Amphur Pluakdaeng Rayong, TH): 6 new FDA device listings, incl. controller, infusion, intravascular, electronic
• Excellent Medical Technology (Thailand) Co., Ltd. (contract manufacturer, U-Thai District Phra Nakhon Si Ayutthaya, TH): 5 new FDA device listings, incl. garment, protective, for incontinence
• Huana Technology (Thailand) Co., Ltd. (manufacturer, Bang Pakong Chachoengsao, TH): 2 new FDA device listings, incl. catheter and tip, suction
• Infus Medical (Thailand) Co., Ltd. (contract manufacturer, Amphoe Muang Samutprakarn Samut Prakan, TH): 3 new FDA device listings, incl. gynecologic power morcellator and containment system
• Molex (Thailand) Ltd. (contract manufacturer, Bangpakong Chachoengsao, TH): 5 new FDA device listings, incl. stimulator, spinal-cord, totally implanted for pain relief
• Puli Healthcare (Thailand) Co., Ltd. (manufacturer, Bangkok Samut Prakan, TH): 29 new FDA device listings, incl. gauze / sponge,nonresorbable for external use
• STERIS TOMOE (Thailand) Ltd. (contract sterilizer, Chonburi Chon Buri, TH): 4 new FDA device listings, incl. fentanyl and other opioid protection glove
• Tianyi Medical (Thailand) Co., Ltd. (contract manufacturer, PLUAKDAENG DISTRICT Rayong, TH): 2 new FDA device listings, incl. syringe, piston

TR

• Burak Global Ic Ve Dis Tic Ltd Sti (foreign exporter, Kocasinan Kayseri, TR): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti (foreign exporter, Maltepe Istanbul, TR): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Mikron Makina Sanayi Ve Ticaret Ltd. Sti. (manufacturer, Ivedik Ankara, TR): 3 new FDA device listings, incl. screw, fixation, bone
• Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi (foreign exporter, Cankaya Ankara, TR): 9 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Zumrut Lens Saglik Hizm. Ve Optik Ur. Dis. Tic. Ltd. Sti. (foreign exporter, FATIH Istanbul, TR): 4 new FDA device listings, incl. lens, contact, (disposable)

TW

• Astron Medtech Co., Ltd. (repackager or relabeler, Taipei, TW): 5 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene
• Hukui Biotechnology Co., Ltd. (contract manufacturer, Zhubei City Hsinchu(County), TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Intai Technology Corp. (contract manufacturer, Taichung City, TW): 2 new FDA device listings, incl. endoscopic tissue approximation device
• Leltek Inc. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Miing Wei Co., Ltd. (contract manufacturer, Tsao-Twon Nantou, TW): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• New Deantronics Taiwan Ltd. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. appliance, fixation, nail/blade/plate combination, multiple component
• Pegavision Corporation (manufacturer, Taoyuan, TW): 4 new FDA device listings, incl. lenses, soft contact, daily wear
• Pegavision Corporation-Daxi (manufacturer, Taoyuan City, TW): 4 new FDA device listings, incl. lenses, soft contact, daily wear
• Savfe Co., Ltd. (manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. system, image processing, radiological
• Syntec Scientific Corp. (contract manufacturer, CHANG HUA Changhua, TW): 6 new FDA device listings, incl. shoulder prosthesis, reverse configuration
• Taiwan Surgical Corporation (manufacturer, Zhubei City Hsinchu(County), TW): 3 new FDA device listings, incl. applier, surgical, clip
• United Orthopedic Corp. (manufacturer, Kaohsiung, TW): 4 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• United Orthopedic Corporation (manufacturer, Hsinchu Hsinchu(County), TW): 4 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Valentine Intl. Ltd. (manufacturer, Hsichih City, Taipei Hsien, TW): 3 new FDA device listings, incl. hook, external limb component, mechanical
• Zimmer Biomet Taiwan Co., Ltd. (foreign exporter, Taipei, TW): 22 new FDA device listings, incl. plate, fixation, bone

Utah

• Acme United Corporation - My Medic (repackager or relabeler, North Salt Lake, UT): 3 new FDA device listings, incl. airway, nasopharyngeal
• Aseptikits, LLC (repackager or relabeler, North Salt Lake, UT): 5 new FDA device listings, incl. syringe, piston
• Bard Access Systems, Inc. (other, Salt Lake City, UT): 14 new FDA device listings, incl. catheter, umbilical artery
• Centerpoint Systems LLC (manufacturer, West Valley City, UT): 4 new FDA device listings, incl. introducer, catheter
• HyperFlex Medical Inc (specification developer, Richmond, UT): 2 new FDA device listings, incl. instrument, compression
• INNO Holdings Inc. (manufacturer, Millcreek, UT): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar
• Isomedix Operations Inc. (contract sterilizer, Sandy, UT): 13 new FDA device listings, incl. plate, fixation, bone
• Laser Marketing Group, LLC (repackager or relabeler, Lehi, UT): 5 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Live Tulani, LLC (repackager or relabeler, Farmington, UT): 6 new FDA device listings, incl. system, test, blood glucose, over the counter
• Medron, LLC (contract manufacturer, Salt Lake City, UT): 2 new FDA device listings, incl. midline catheter
• Merit Medical Systems, Inc. (manufacturer, South Jordan, UT): 7 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology
• Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, UT): 51 new FDA device listings, incl. system, ablation, microwave and accessories
• Total Joint Orthopedics, Inc. (specification developer, Salt Lake City, UT): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol
• Ultradent Products Inc. (manufacturer, South Jordan, UT): 3 new FDA device listings, incl. varnish, cavity
• Zigg Design LLC (contract manufacturer, Nibley, UT): 33 new FDA device listings, incl. orthosis, spine, plate, laminoplasty, metal

Virginia

• Avid Medical, Inc. A Medical Action Ind. Company 305 (manufacturer, Toano, VA): 4 new FDA device listings, incl. truss, umbilical
• Intent Brands LLC (repackager or relabeler, Falls Church, VA): 9 new FDA device listings, incl. lubricant, patient
• Mfg One, LLC (contract manufacturer, Chantilly, VA): 6 new FDA device listings, incl. warmer, thermal, infusion fluid
• S. Jackson, Inc. (manufacturer, Alexandria, VA): 4 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyamide

VN

• Anctek Viet Nam Company Limited (contract manufacturer, Bien Hoa Dong Nai, VN): 3 new FDA device listings, incl. light based over the counter wrinkle reduction
• B And B Investment Company Limited (foreign exporter, Ha Dong Ward Ha Noi, VN): 12 new FDA device listings, incl. tubes, vacuum sample, with anticoagulant
• Basic International Viet Nam Co.,Ltd (manufacturer, QUANG TRUNG WARD Thanh Hoa, VN): 4 new FDA device listings, incl. medical glove, specialty
• Comatrix Technology Vietnam Company Limited (contract manufacturer, Ho Chi Minh City, VN): 11 new FDA device listings, incl. joint, knee, external brace
• Cometech Vn Company Limited (contract manufacturer, Phu Thanh Ward Ho Chi Minh, VN): 7 new FDA device listings, incl. teeth, artificial, posterior with metal insert
• Environstar Group Company Limited (contract manufacturer, Hung Yen Province, VN): 2 new FDA device listings, incl. gown, surgical
• MZ Vietnam Co.,LTD (contract manufacturer, tan thuan ward Ho Chi Minh, VN): 4 new FDA device listings, incl. accessories, wheelchair
• Nam Ha Viet Nam Trading Company Limited (repackager or relabeler, Hanoi Ha Noi, VN): 3 new FDA device listings, incl. set, administration, intravascular
• Ogawa Wellness Vietnam Company Limited (manufacturer, Long An, VN): 2 new FDA device listings, incl. over-the-counter powered light based laser for acne
• Phu Bao Medical Co., Ltd (manufacturer, Long An Province, VN): 2 new FDA device listings, incl. mask, surgical
• S&S Glove Corporation (manufacturer, Ho Chi Minh City, VN): 4 new FDA device listings, incl. medical glove, specialty
• S&S Glove Corporation- Branch 1 (contract manufacturer, Ho Chi Minh City Ba Ria-Vung Tau, VN): 4 new FDA device listings, incl. fentanyl and other opioid protection glove
• Tam Viet Distribution Company Limited (foreign exporter, Ho Chi Minh, VN): 17 new FDA device listings, incl. set, administration, intravascular
• Thanh Hoa Medical Technology Co., Ltd. (manufacturer, QUANG TRUNG WARD Thanh Hoa, VN): 4 new FDA device listings, incl. medical gloves with chemotherapy labeling claims - test for use with c
• Viemedi Global Co., Ltd. (contract manufacturer, Vinh Tan Ward Ho Chi Minh, VN): 2 new FDA device listings, incl. sleeve, limb, compressible
• WU'S TECH (VIETNAM) Co., Ltd. (contract manufacturer, Ho Chi Minh City Binh Duong, VN): 2 new FDA device listings, incl. wheelchair, powered
• Yong Yi Viet Nam Co.,Ltd (contract manufacturer, Duc Hoa Commune Tay Ninh, VN): 2 new FDA device listings, incl. adaptor, dressing

Washington

• Acme United Corp. (repackager or relabeler, Vancouver, WA): 2 new FDA device listings, incl. dressing, wound, occlusive
• Fujifilm Sonosite,Inc. (manufacturer, Bothell, WA): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Mackay Manufacturing, Inc. (contract manufacturer, Spokane Valley, WA): 11 new FDA device listings, incl. orthopedic stereotaxic instrument
• Philips Ultrasound LLC (manufacturer, Bothell, WA): 36 new FDA device listings, incl. catheter, ultrasound, intravascular
• Siemens Medical Solutions USA, Inc. (manufacturer, Issaquah, WA): 7 new FDA device listings, incl. biopsy needle guide kit

West Virginia

• Alcon Research, LLC (manufacturer, Huntington, WV): 3 new FDA device listings, incl. extended depth of focus intraocular lens
• Alcon Research, LLC (manufacturer, Lesage, WV): 3 new FDA device listings, incl. lens, intraocular, toric optics

Wisconsin

• Datex-Ohmeda, Inc. (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, monitoring, perinatal
• GE Medical Systems Information Technologies, Inc. (specification developer, Waukesha, WI): 26 new FDA device listings, incl. analyzer, gas, carbon-dioxide, gaseous-phase
• GE Medical Systems Information Technologies, Inc. (specification developer, Wauwatosa, WI): 26 new FDA device listings, incl. analyzer, gas, carbon-dioxide, gaseous-phase
• GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC (specification developer, Waukesha, WI): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Ge Medical Systems, LLC (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, nuclear magnetic resonance imaging
• Hm Product Solutions, Ltd. (contract manufacturer, Hartland, WI): 3 new FDA device listings, incl. system, x-ray, tomography, computed
• Icp, Inc. (specification developer, Green Bay, WI): 5 new FDA device listings, incl. band, elastic, orthodontic
• Inter-Med, Inc. (manufacturer, Racine, WI): 3 new FDA device listings, incl. cement, dental
• Merz North America, Inc. (other, Sturtevant, WI): 4 new FDA device listings, incl. implant, dermal, for aesthetic use
• Performance Health Supply, LLC. (specification developer, Cedarburg, WI): 3 new FDA device listings, incl. esthesiometer
• Uline, Inc. (repackager or relabeler, Pleasant Prairie, WI): 4 new FDA device listings, incl. latex patient examination glove

ZA

• Coba Biomedical PTY (Ltd) (contract manufacturer, Bloemfontein Free State, ZA): 27 new FDA device listings, incl. hook, ophthalmic

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