DeviceEstablishmentPulse: all 1,000 record reports, page 2 of 5

Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 201 to 400: Ge Medical Systems (China) Co., Ltd. (manufacturer, WUXI Jiangsu, CN): 45 new FDA device listings, incl. automated radiological image processing software to Karl Storz Se & Co Kg (specification developer, TUTTLINGEN Baden-Wurttemberg, DE): 15 new FDA device listings, incl. hysteroscope (and accessories). Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

CN

• Ge Medical Systems (China) Co., Ltd. (manufacturer, WUXI Jiangsu, CN): 45 new FDA device listings, incl. automated radiological image processing software
• Gn Resound China, Ltd. (contract manufacturer, XIAMEN Fujian, CN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter
• Guang Zhou Medclear Medical Device Service Co., Ltd. (contract sterilizer, Dongguan Guangdong, CN): 3 new FDA device listings, incl. mirror, mouth
• Guangdong Carain Beauty Equipment Co., Ltd (contract manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. powered microneedle device
• Guangdong Kelihuan Biotechnology Co., Ltd. (manufacturer, Huizhou Guangdong, CN): 5 new FDA device listings, incl. applicator, ent
• Guangdong MacroLux Medical Technology Co., Ltd. (contract manufacturer, Dongguan Guangdong, CN): 7 new FDA device listings, incl. cystoscope and accessories, flexible/rigid
• Guangdong Titan Smart Electrical Appliance Co., Ltd. (manufacturer, Zhongshan Guangdong, CN): 8 new FDA device listings, incl. splint, clavicle
• Guangdong Transtek Medical Electronics Co.,Ltd (contract manufacturer, Zhongshan Guangdong, CN): 4 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• Guangdong Youmeng Electrical Technology Co., Ltd. (contract manufacturer, Foshan Guangdong, CN): 2 new FDA device listings, incl. pump, breast, powered
• Guangzhou Aimei Intelligent Technology Co., Ltd. (manufacturer, Guangzhou Guangdong, CN): 3 new FDA device listings, incl. blade, scalpel
• Guangzhou Bioway Medical Technology Joint-Stock Co.,Ltd. (manufacturer, Guangzhou Guangdong, CN): 5 new FDA device listings, incl. accessories, wheelchair
• Guangzhou Decheng Biotechnology Co., Ltd. (manufacturer, Guangzhou Guangdong, CN): 2 new FDA device listings, incl. radioimmunoassay, estrone
• Guangzhou Four E's Scientific Co., Ltd. (manufacturer, GUANGZHOU Guangdong, CN): 4 new FDA device listings, incl. table, slide warming
• Guangzhou Nanqixing Nonwoven Co., Ltd. (manufacturer, guangzhou Guangdong, CN): 5 new FDA device listings, incl. mask, scavenging
• Guangzhou Niansheng Beauty Equipment Co., Ltd. (contract manufacturer, Guangzhou Guangdong, CN): 4 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• Guangzhou Wondfo Biotech Co., Ltd. (manufacturer, Dongguan Guangdong, CN): 11 new FDA device listings, incl. test, propoxyphene, over the counter
• Guangzhou Wondfo Biotech Co., Ltd. (manufacturer, Guangzhou Guangdong, CN): 11 new FDA device listings, incl. test, propoxyphene, over the counter
• Guilin Kevin Peter Technology Co., Ltd. (manufacturer, Guilin Guangxi, CN): 7 new FDA device listings, incl. light, examination, medical, battery powered
• Gushi priMED Medical Products Manufacturing Co., Ltd. (manufacturer, Gushi County Henan, CN): 2 new FDA device listings, incl. medical gowns with chemotherapy labeling claims - tested for use with
• Hangzhou AGS MedTech Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 4 new FDA device listings, incl. hemostatic metal clip for the gi tract
• Hangzhou Qiantang Longyue Biotechnology Co.,Ltd (manufacturer, Hangzhou Zhejiang, CN): 2 new FDA device listings, incl. set, i.v. fluid transfer
• Hangzhou Shining3d Dental Technology Co., Ltd (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. crown and bridge, temporary, resin
• Hangzhou Tongzhou Biotechnology Co., Ltd (repackager or relabeler, Hangzhou Zhejiang, CN): 59 new FDA device listings, incl. test, tricyclic antidepressants, over the counter
• HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. Ltd (foreign exporter, Hangzhou City Zhejiang, CN): 3 new FDA device listings, incl. clinical electronic thermometer
• Hebei Junlaole Medical Technology Co.,Ltd (manufacturer, Hengshui City Hebei, CN): 3 new FDA device listings, incl. exerciser, non-measuring
• Hebei Lufen Tech Co., Limited (contract sterilizer, Xingtai Hebei, CN): 3 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter
• Hefei Baoguo Information Technology Co., Ltd (specification developer, Hefei Anhui, CN): 12 new FDA device listings, incl. pad, eye
• Hefei Haixi Trading Co., Ltd. (repackager or relabeler, Hefei Anhui, CN): 5 new FDA device listings, incl. syringe, irrigating (non dental)
• Hengshui Shuntai Kangyuan Medical Equipment Co.,Ltd (manufacturer, Hengshui Hebei, CN): 11 new FDA device listings, incl. chair and table, medical
• Hing Ka Yuen Health Technology (Changzhou )co., Ltd (manufacturer, Changzhou Jiangsu, CN): 7 new FDA device listings, incl. instrument, surgical, orthopedic, ac-powered motor and accessory/attac
• Hubei Guarddent Medical Technology Co.,Ltd (manufacturer, Wuhan Hubei, CN): 10 new FDA device listings, incl. pusher, band, orthodontic
• Hubei Qianjiang Kingphar Medical Material Co., Ltd (manufacturer, Qianjiang, Hubei, CN): 4 new FDA device listings, incl. holder, ureteral catheter
• Huizhou Videya Technology Co., Ltd. (manufacturer, Huizhou Guangdong, CN): 3 new FDA device listings, incl. intraoral camera
• Hynaut Health Technology Co., LTD. (contract manufacturer, Qingdao Shandong, CN): 7 new FDA device listings, incl. catheter, infusion
• Integral Sterilization Technology (Shaoxing) Co., Ltd (contract sterilizer, Shaoxing Zhejiang, CN): 10 new FDA device listings, incl. catheter, urethral
• Jiangsu Assure Medical Equipment Co., Ltd (contract manufacturer, ZHENJIANG CITY Jiangsu, CN): 4 new FDA device listings, incl. belt, wheelchair
• Jiangsu Hongsheng Bioengineering Co., Ltd. (manufacturer, Nantong Jiangsu, CN): 3 new FDA device listings, incl. dressing, wound, hydrophilic
• Jiangsu Huida Medical Instruments Co., Ltd (manufacturer, Yancheng Jiangsu, CN): 2 new FDA device listings, incl. filters, cell collection, tissue processing
• Jiangsu New Pentastar Medical Products Co. Ltd. (foreign exporter, Changzhou Jiangsu, CN): 13 new FDA device listings, incl. bath, sitz, nonpowered
• Jiangsu Optimum Optics Co., Ltd. (manufacturer, Danyang Jiangsu, CN): 4 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Jiangsu Pinkang Medical Technology Co Ltd (contract manufacturer, Danyang Jiangsu, CN): 4 new FDA device listings, incl. wheelchair, mechanical
• Jiangsu Xiangyu Fitness Equipment Co., Ltd. (contract manufacturer, Yangzhong Jiangsu, CN): 2 new FDA device listings, incl. orthosis, rib fracture, soft
• Jiangxi Rekonova Dental Materials Co., Ltd. (contract manufacturer, Jiujiang Jiangxi, CN): 2 new FDA device listings, incl. powder, porcelain
• Jinhua Jingdi Medical Supplies Co.,Ltd (contract manufacturer, Jinhua Zhejiang, CN): 8 new FDA device listings, incl. tape and bandage, adhesive, adjustable closing mechanism, otc use
• Jm Medical Co., Ltd. (manufacturer, Liaocheng Shandong, CN): 8 new FDA device listings, incl. bandage, cast
• Jome Commodity Co.,Ltd. (manufacturer, Ningbo Zhejiang, CN): 11 new FDA device listings, incl. applicator, absorbent tipped, non-sterile
• Joytech Healthcare Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• Kingstar Medical (Xianning) Co., Ltd. (contract manufacturer, Xianning City Hubei, CN): 3 new FDA device listings, incl. applicator, absorbent tipped, non-sterile
• Lakong Medical Devices Co., Ltd. (manufacturer, Dongguan Guangdong, CN): 4 new FDA device listings, incl. portable dental operative unit
• Liaoning Dikangyuan Health Technology Co.,Ltd. (contract manufacturer, LIAOYANG Liaoning, CN): 4 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Liaoning Xinaite Technology Co.,Ltd (manufacturer, benxi Liaoning, CN): 3 new FDA device listings, incl. material, impression tray, resin
• Linc Medipharm Limited (foreign exporter, Wuxi Jiangsu, CN): 13 new FDA device listings, incl. syringe, piston
• Lincotek (Wuxi) Co., Ltd. (contract manufacturer, Wuxi Jiangsu, CN): 6 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer
• Lingshi Hongruida Health Protection Technology Co., Ltd. (manufacturer, Jinzhong City Shanxi, CN): 2 new FDA device listings, incl. medical glove, specialty
• Macrolux Medical Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 6 new FDA device listings, incl. cystoscope and accessories, flexible/rigid
• Meda Co., Ltd. (manufacturer, Tianjin, CN): 2 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Micro-Energy Medical Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. accessories, catheter
• Micro-Tech (Nanjing) Co., Ltd. (manufacturer, NAN JING Jiangsu, CN): 2 new FDA device listings, incl. endoscopic injection needle, gastroenterology-urology
• Micro-Tech (Nanjing) Co., Ltd. (manufacturer, Nanjing Jiangsu, CN): 2 new FDA device listings, incl. endoscopic injection needle, gastroenterology-urology
• Miniso Development Hong Kong Limited (repackager or relabeler, SAN PO KONG KL Hong Kong, CN): 6 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Nanjing Anjian Medical Device Co.,Ltd. (foreign exporter, Nanjing Jiangsu, CN): 6 new FDA device listings, incl. disinfectant, medical devices
• Ningbo Chengyue Crafts Co.,Ltd (foreign exporter, NingBo Zhejiang, CN): 5 new FDA device listings, incl. toothbrush, manual
• Ningbo Denrotary Medical Apparatus Co., Ltd. (contract manufacturer, Ningbo City Zhejiang, CN): 9 new FDA device listings, incl. bracket, metal, orthodontic
• Ningbo Divalux Imp & Exp. Corp. (manufacturer, Ningbo Zhejiang, CN): 5 new FDA device listings, incl. toothbrush, powered
• Ningbo Greetmed Medical Instruments Co., Ltd. (specification developer, Ningbo Zhejiang, CN): 2 new FDA device listings, incl. electrode, electrocardiograph
• Ningbo Guangbo Medical Technology Co.,Ltd (manufacturer, Ningbo Zhejiang, CN): 6 new FDA device listings, incl. adhesive backed thermal skin patches
• Ningbo Kehu Medical Technology Co.,Ltd. (specification developer, Ningbo Zhejiang, CN): 7 new FDA device listings, incl. tape and bandage, adhesive
• Ningbo Landing Technology Company Co., Ltd. (manufacturer, Ningbo Zhejiang, CN): 3 new FDA device listings, incl. hearing aid, air-conduction with wireless technology, over the counter
• Ningbo Sincerecare Import And Export Co.,Ltd (foreign exporter, NINGBO Zhejiang, CN): 2 new FDA device listings, incl. container, specimen, non-sterile
• Northstar Trade Co., Limited (foreign exporter, Mongkok KL Hong Kong, CN): 2 new FDA device listings, incl. bracket, plastic, orthodontic
• Orantech Inc. (foreign exporter, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Paragon Medical Device (Changzhou) Co., Ltd. (contract manufacturer, Changzhou Jiangsu, CN): 5 new FDA device listings, incl. elevator
• Peter's Technology (Suzhou) Co., Ltd. (contract manufacturer, Suzhou Jiangsu, CN): 9 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Primed Liyang Medical Products Manufacturing Co., Ltd. (manufacturer, Liyang Jiangsu, CN): 2 new FDA device listings, incl. medical gowns with chemotherapy labeling claims - tested for use with
• Qinhuangdao Audental Metal Technology Co., Ltd. (manufacturer, Qinhuangdao City Hebei, CN): 7 new FDA device listings, incl. restoration, porcelain
• Ryder Electronics (Shenzhen) Ltd. (contract manufacturer, Shenzhen Guangdong, CN): 9 new FDA device listings, incl. electrocardiograph
• Ryder Electronics (Xinfeng) Ltd. (contract manufacturer, Ganzhou City Jiangxi, CN): 2 new FDA device listings, incl. pad, heating, powered
• Saint-Gobain Life Sciences (Hangzhou) Co., Ltd (contract manufacturer, Hangzhou Zhejiang, CN): 27 new FDA device listings, incl. accessories, germicide, cleaning, for endoscopes
• Sanhe LEFIS Electronics Co.,Ltd (manufacturer, langfang Hebei, CN): 2 new FDA device listings, incl. powered laser surgical instrument
• Shandong Lianfa Medical Plastic Products Co. Ltd. (manufacturer, JINAN Shandong, CN): 3 new FDA device listings, incl. tape and bandage, adhesive
• Shandong Moonlight Electronics Tech Co.,Ltd. (manufacturer, Weifang Shandong, CN): 3 new FDA device listings, incl. device, rebreathing
• Shanghai Eder Medical Technology Inc. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. microscope, operating & accessories, ac-powered, ophthalmic
• Shanghai Hua En Industrial Co Ltd (repackager or relabeler, Shanghai, CN): 7 new FDA device listings, incl. syringe, piston
• Shanghai Jolly Industrial Co., Ltd. (contract manufacturer, Shanghai, CN): 18 new FDA device listings, incl. pack, hot or cold, disposable
• Shanghai Jpy Ion-Tech Co., Ltd. (contract sterilizer, Shanghai, CN): 16 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Shanghai Link Instruments Co.,Ltd (manufacturer, Changzhou City Jiangsu, CN): 3 new FDA device listings, incl. ophthalmoscope, battery-powered
• Shanghai Wallaby Medical Technologies CO., Inc. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. catheter, percutaneous, neurovasculature
• Shanghai Yijian International Trade Co., Ltd. (manufacturer, shannhai Shanghai, CN): 4 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Shanghai Youchi Material Tech Co., Ltd (foreign exporter, Shanghai, CN): 3 new FDA device listings, incl. cover, mattress (medical purposes)
• Shantou Institute Of Ultrasonic Instruments Co., Ltd. (manufacturer, Shantou Guangdong, CN): 3 new FDA device listings, incl. system, x-ray, mobile
• Shantou Institute Of Ultrasonic Instruments Co., Ltd. (manufacturer, SHANTOU Guangdong, CN): 3 new FDA device listings, incl. system, x-ray, mobile
• Shenzhen Bi-Rich Medical Devices Co., Ltd (contract manufacturer, Shenzhen City Guangdong, CN): 2 new FDA device listings, incl. meter, peak flow, spirometry
• Shenzhen Chuangtong Yigou Technology Co., Ltd (manufacturer, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Shenzhen Ctlite Technology Co.,Ltd (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. massager, therapeutic, electric
• Shenzhen Hengbosi Industrial Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 9 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• Shenzhen Huayan E-Commerce Co., Ltd. (foreign exporter, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. oximeter, wellness
• Shenzhen Hugemed Medical Technical Development Co., Ltd (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. stand, infusion
• Shenzhen Jpy Ion-Tech. Co., Ltd. (contract sterilizer, Shenzhen Guangdong, CN): 37 new FDA device listings, incl. dressing, wound, hydrophilic
• Shenzhen Kaiyan Medical Equipment Co., Ltd (contract manufacturer, Shenzhen Guangdong, CN): 12 new FDA device listings, incl. light based over the counter wrinkle reduction
• Shenzhen Kesite Digital Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. collector, urine, powered, non indwelling catheter
• Shenzhen Langzhiyin Electronic Co.,Ltd. (manufacturer, Shenzhen Guangdong, CN): 5 new FDA device listings, incl. massager, therapeutic, manual
• Shenzhen Leshang Technology Design Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. spectacle, magnifying
• Shenzhen Lincond Technology Co.,Ltd. (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Shenzhen Mareal Tech Co., Ltd (contract manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. light based over-the-counter hair removal
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 39 new FDA device listings, incl. detector and alarm, arrhythmia
• Shenzhen Mindray Bio-Medical Electronics Co.,LTD (specification developer, SHENZHEN Guangdong, CN): 39 new FDA device listings, incl. detector and alarm, arrhythmia
• Shenzhen New Industries Biomedical Engineering Co.,Ltd (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. equipment, laboratory, general purpose, labeled or promoted for a spec
• Shenzhen OSTO Medical Technology Company Limited (manufacturer, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• Shenzhen Qinglai Innovative Intelligent Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. frame, spectacle
• Shenzhen Rainbow Light Medical Equipment Co., Ltd (foreign exporter, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. over-the-counter powered light based laser for acne
• Shenzhen Root Innovation Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 4 new FDA device listings, incl. pump, breast, powered
• Shenzhen Samo Technology Co.,Limited (manufacturer, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. cleaner, ultrasonic, medical instrument
• Shenzhen Sany Pioneer Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 5 new FDA device listings, incl. set, tubing and support, ventilator (w harness)
• Shenzhen Tph Technology Co., Ltd. (contract manufacturer, Shenzhen Guangdong, CN): 7 new FDA device listings, incl. pump, breast, powered
• Shenzhen Yingchi Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. extracranial positional system for a transcranial magnetic stimulation
• Shenzhen Youyou Technology Co., Ltd. (contract manufacturer, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. hearing aid, air-conduction, over the counter
• Shenzhen Ziqing Medical Equipment Co., Ltd (manufacturer, Shenzhen Guangdong, CN): 2 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• Shijiazhuang Aofeite Medical Device Co.,Ltd (manufacturer, Shijiazhuang Hebei, CN): 3 new FDA device listings, incl. splint, hand, and components
• Siemens Shanghai, Medical Equipment Ltd. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager)
• Siemens Shenzhen Magnetic Resonance Ltd. (manufacturer, SHENZHEN Guangdong, CN): 5 new FDA device listings, incl. system, nuclear magnetic resonance imaging
• Something High Electric (Xiamen) Company Inc. (contract manufacturer, Xiamen Fujian, CN): 3 new FDA device listings, incl. non-implanted electrical stimulation device for management of prematur
• Sonoscape Medical Corp. (manufacturer, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Sonoscape Medical Corp. (manufacturer, SHENZHEN Guangdong, CN): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Sterigenics Shanghai E Beam Ltd. (contract sterilizer, Shanghai, CN): 2 new FDA device listings, incl. catheter, straight
• Sterigenics Shanghai ETO Ltd. (contract sterilizer, Shanghai, CN): 4 new FDA device listings, incl. gown, surgical
• Sterilance Medical (Suzhou) Inc. (manufacturer, Suzhou Jiangsu, CN): 3 new FDA device listings, incl. single use only blood lancet without an integral sharps injury prevent
• Suzhou Kangli Orthopaedics Instrument Co., Ltd. (contract manufacturer, Zhangjiagang City Jiangsu, CN): 3 new FDA device listings, incl. screw, fixation, bone
• Suzhou Minhua Medical Equipment Co.,Ltd. (contract manufacturer, SuZhou Jiangsu, CN): 2 new FDA device listings, incl. cushion, flotation
• Suzhou Prosteri Medical Technology Co., Ltd. (contract sterilizer, Suzhou Jiangsu, CN): 7 new FDA device listings, incl. device, neurovascular embolization
• Suzhou Pulikang Medical Device Co Ltd (manufacturer, Suzhou Jiangsu, CN): 2 new FDA device listings, incl. cup, eye
• Suzhou Zenith Vascular Scitech Limited (manufacturer, Suzhou Jiangsu, CN): 7 new FDA device listings, incl. catheter, percutaneous
• Taizhou Chenguang Import And Export Trading Co., Ltd. (foreign exporter, Taizhou Jiangsu, CN): 23 new FDA device listings, incl. dressing, wound, hydrogel without drug and/or biologic
• Taizhou Lvnsa Trading Co., Ltd. (contract manufacturer, Taizhou Zhejiang, CN): 3 new FDA device listings, incl. frame, spectacle
• Taizhou Padeng Glasses Co., Ltd. (manufacturer, LINHAI Zhejiang, CN): 5 new FDA device listings, incl. lens, spectacle, non-custom (prescription)
• Taizhou Xinkang Medical Materials Co., Ltd (manufacturer, Taizhou Jiangsu, CN): 2 new FDA device listings, incl. first aid kit with drug
• Tianjin Huahong Technology Co., Ltd. (manufacturer, Tianjin, CN): 2 new FDA device listings, incl. needle, hypodermic, single lumen
• Turnxon Precision Co., Ltd (contract manufacturer, Dongguan Guangdong, CN): 3 new FDA device listings, incl. extractor
• Vivachek Biotech (Hangzhou) Co., Ltd (manufacturer, Hangzhou, Zhuji Zhejiang, CN): 12 new FDA device listings, incl. enzyme immunoassay, phencyclidine
• Weifang Keepbetter Healthcare Co., Ltd. (manufacturer, Weifang Shandong, CN): 5 new FDA device listings, incl. fiber, medical, absorbent
• Weihai Jieshi Commodity Manufacture Co. Ltd. (manufacturer, Weihai,Shandong, CN): 2 new FDA device listings, incl. cleanser, denture, over the counter
• Wenzhou Baiyu Glasses Technology Co.,Ltd (contract manufacturer, Wenzhou Zhejiang, CN): 6 new FDA device listings, incl. dressing, wound, hydrogel without drug and/or biologic
• Wenzhou Ezekiel Creative Electronic Technology Co., Ltd. (manufacturer, Wenzhou Zhejiang, CN): 4 new FDA device listings, incl. massager, therapeutic, electric
• Winner Medical (Hunan) Co., Ltd. (contract manufacturer, Changde Hunan, CN): 6 new FDA device listings, incl. parenteral administration kit
• Wuhan Landing Intelligence Medical Co.,Ltd (manufacturer, Wuhan Hubei, CN): 5 new FDA device listings, incl. pap smear kit
• Wuhan Pakcare Bio-Technology Co., Ltd. (manufacturer, Wuhan City Hubei, CN): 2 new FDA device listings, incl. pack, hot or cold, water circulating
• Wuhan United Imaging Healthcare Co.,Ltd. (manufacturer, Wuhan Hubei, CN): 8 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Xiamen Firstcare Imp. & Exp. Co.,Ltd. (foreign exporter, Xiamen Fujian, CN): 11 new FDA device listings, incl. clinical electronic thermometer
• Xiamen Kingda Industry Co., Ltd. (manufacturer, Xiamen City Fujian, CN): 4 new FDA device listings, incl. garment, protective, for incontinence
• Xiamen Weiyou Intelligent Technology Co.,Ltd (manufacturer, xiamen Fujian, CN): 4 new FDA device listings, incl. massager, powered inflatable tube
• Yadu Medical (Henan) Co., Ltd (manufacturer, Changyuan Henan, CN): 4 new FDA device listings, incl. tray, surgical, instrument
• Yangzhou Aolikes Sports Goods Co., Ltd. (manufacturer, Yangzhou Jiangsu, CN): 3 new FDA device listings, incl. orthosis, thoracic
• Yangzhou Fartley Medical Instrument Technology Co., Ltd (manufacturer, Yangzhou Jiangsu, CN): 2 new FDA device listings, incl. colonoscope and accessories, flexible/rigid
• Yiwu Inwell Craft&Gift Co.,Ltd (contract manufacturer, Jin Hua Zhejiang, CN): 10 new FDA device listings, incl. laser, comb, hair
• Yiwu Ori-Power Medtech Co., Ltd. (manufacturer, YIWU Zhejiang, CN): 2 new FDA device listings, incl. mask, surgical
• Yongkang Joymax Medical Technology Co.,Ltd (manufacturer, Jinhua Zhejiang, CN): 2 new FDA device listings, incl. wheelchair, powered
• Yunbo Times (Taizhou) Technology Co. Ltd. (foreign exporter, Taizhou Zhejiang, CN): 3 new FDA device listings, incl. pad, menstrual, unscented
• Yuyao Nature Industry And Trade Co., Ltd. (manufacturer, Yuyao Zhejiang, CN): 2 new FDA device listings, incl. massager, therapeutic, manual
• Zhangjiagang New Fellow Med Co., Ltd. (manufacturer, Zhangjiagang Jiangsu, CN): 16 new FDA device listings, incl. stretcher, wheeled
• Zhejiang Biomet Medical Products Co., Ltd. (contract manufacturer, Jinhua Zhejiang, CN): 6 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Zhejiang Decans Medical Devices Co.,Ltd. (manufacturer, Jiaxing Zhejiang, CN): 13 new FDA device listings, incl. appliance, fixation, spinal intervertebral body
• Zhejiang Innuovo Rehabilitation Devices Co., Ltd. (contract manufacturer, Dongyang Zhejiang, CN): 5 new FDA device listings, incl. wheelchair, powered
• Zhejiang Kindly Medical Devices Co., Ltd (contract manufacturer, WENZHOU Zhejiang, CN): 3 new FDA device listings, incl. needle, hypodermic, single lumen
• Zhejiang Lidesen Medical Instrument Co., Ltd (contract manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. instrument, manual, surgical, general use
• ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd (contract manufacturer, HANGZHOU Zhejiang, CN): 2 new FDA device listings, incl. syringe, piston
• Zhejiang Mateside Medical Devices Technology Co., Ltd (contract manufacturer, Ningbo Zhejiang, CN): 3 new FDA device listings, incl. device, anti-tip, wheelchair
• Zhejiang Yusen Hygiene Products Co., Ltd (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. disinfectant, medical devices
• Zhengzhou Pz Laser Slim Technology Co., Ltd (manufacturer, Zhengzhou City Henan, CN): 6 new FDA device listings, incl. powered laser surgical instrument
• Zhengzhou Youtai Health Technology Co., Ltd. (manufacturer, Zhengzhou Henan, CN): 3 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Zhengzhou Zhongkemei Health Technology Co., Ltd. (manufacturer, Shangjie District Henan, CN): 3 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Zhenjiang Assure Medical Equipment Co Ltd (manufacturer, ZHENJIANG CITY Jiangsu, CN): 4 new FDA device listings, incl. wheelchair, mechanical
• Zhuhai Quin Technology Co., Ltd. (repackager or relabeler, ZHUHAI Guangdong, CN): 4 new FDA device listings, incl. lamp, infrared, therapeutic heating
• Zimmer (Shanghai) Medical International Trading Co., Ltd. (foreign exporter, Shanghai, CN): 14 new FDA device listings, incl. plate, fixation, bone
• Zuo Chuan Eyewear Co., Ltd., Danyang City (manufacturer, Zhenjiang Jiangsu, CN): 5 new FDA device listings, incl. frame, spectacle

Colorado

• Acertara Acoustic Laboratories, LLC (contract manufacturer, Longmont, CO): 2 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Altivera Medical, Inc. (repackager or relabeler, Englewood, CO): 6 new FDA device listings, incl. orthosis, limb brace
• Aspero Medical, Inc. (specification developer, Westminster, CO): 2 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology
• Boulder Biomed LLC (contract sterilizer, Boulder, CO): 2 new FDA device listings, incl. clamp, vascular
• Cleerly, Inc (manufacturer, Denver, CO): 3 new FDA device listings, incl. system, image processing, radiological
• Covidien (manufacturer, Boulder, CO): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Covidien (specification developer, Lafayette, CO): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Covidien (specification developer, Lafayette, CO): 5 new FDA device listings, incl. tube, tracheal (w/wo connector)
• Ischemaview, Inc. (manufacturer, Golden, CO): 4 new FDA device listings, incl. system, image processing, radiological
• LivaNova USA, INC. (contract manufacturer, Arvada, CO): 5 new FDA device listings, incl. catheter, cannula and tubing, vascular, cardiopulmonary bypass
• Materialise Colombia S.A.S (manufacturer, Medellin Antioquia, CO): 3 new FDA device listings, incl. shoulder arthroplasty implantation system
• Neuralytix LLC (specification developer, Fruita, CO): 2 new FDA device listings, incl. stimulator, nerve
• Paragon 28 (manufacturer, Englewood, CO): 9 new FDA device listings, incl. kit, surgical instrument, disposable
• Ronexmed S.A.S. (contract manufacturer, Barranquilla Atlantico, CO): 3 new FDA device listings, incl. cover, mattress (medical purposes)
• Simple Style Inc (specification developer, Brighton, CO): 10 new FDA device listings, incl. bandage, elastic
• Terumo BCT STERILIZATION SERVICES, Inc. (contract sterilizer, Lakewood, CO): 6 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology

Connecticut

• Abyrx, Inc. (manufacturer, Stamford, CT): 7 new FDA device listings, incl. wax, bone
• Coopersurgical, Inc. (manufacturer, Trumbull, CT): 10 new FDA device listings, incl. fetal head elevator
• Integrated Medcraft LLC (repackager or relabeler, East Hampton, CT): 3 new FDA device listings, incl. catheter guide wire kit
• Linemaster Switch Corp. (contract manufacturer, Woodstock, CT): 7 new FDA device listings, incl. system, surgical, computer controlled instrument
• Oravance Wellness LLC. (other, Westport, CT): 2 new FDA device listings, incl. heat source for bleaching teeth
• Spine Wave, Inc. (manufacturer, Shelton, CT): 6 new FDA device listings, incl. bit, drill
• TOMZ Corporation (contract manufacturer, Berlin, CT): 36 new FDA device listings, incl. appliance, fixation, spinal interlaminal
• Trumedx LLC (other, Shelton, CT): 5 new FDA device listings, incl. lamp, infrared, therapeutic heating

Delaware

• Draegerwerk AG & Co. KGaA (manufacturer, LUEBECK Schleswig-Holstein, DE): 5 new FDA device listings, incl. support, breathing tube
• Dreame Technology USA Inc (specification developer, Newark, DE): 4 new FDA device listings, incl. floss, dental
• Karl Storz Se & Co Kg (specification developer, TUTTLINGEN Baden-Wurttemberg, DE): 15 new FDA device listings, incl. hysteroscope (and accessories)

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