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Data / Medical devices / Syringe, Irrigating (Non Dental)

Syringe, Irrigating (Non Dental) (KYZ): 226 FDA-registered makers in 24 countries

226 establishments in 24 countries are registered with the FDA to make Syringe, Irrigating (Non Dental) (product code KYZ, Class 1, 21 CFR 880.6960). 6 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on November 5, 2020, and lists 15 recall events (1 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
KYZ
Device class
1
Regulation
880.6960
Medical specialty
General Hospital

Makers by country

CountryMakers
China81
United States72
Germany20
Pakistan11
Mexico7
India7
Taiwan5
Thailand3
Vietnam3
Canada2
Israel2
Dominican Republic1
Switzerland1
Ireland1
Cambodia1
Singapore1
Malaysia1
South Korea1
Honduras1
Indonesia1
United Arab Emirates1
Latvia1
Turkey1
New Zealand1

Makers of Syringe, Irrigating (Non Dental)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Micromedics, Inc.Saint Paul, MN, United StatesManufacturer3March 15, 2011010api.fda.gov
Nordson MEDICAL MexicoGuaymas Sonora, MexicoContract manufacturer, Exporter to the US2March 15, 2011000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Repackager or relabeler1February 17, 1981000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer1June 7, 1993030api.fda.gov
MAR-MED Inc.Grand Rapids, MI, United StatesManufacturer1September 4, 1990000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer1November 20, 1981000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Aena Medical (jiangsu) Co.,ltd.Jiangyin City Jiangsu, ChinaManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Albert Hohlkoerper GMBH & Co. KGHEMER North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Alger Technology Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Anhui Easyway Medical Supplies Co., LtdTian Chang Anhui, ChinaManufacturer0000api.fda.gov
Anhui Yixiang Trading Co., LtdHefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Asia Connection Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Aimi Health Technology (Guangdong) Co., Ltd.Dongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov
B. Braun Medical AGESCHOLZMATT Luzern, SwitzerlandContract manufacturer0000api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyExporter to the US, Specification developer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Bauer Und Haselbarth-Chirurg GMBHELLERAU Schleswig-Holstein, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Biomed Plastics Co.Taicang, Jiangsu, ChinaManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Bionix, LLCMaumee, OH, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Biorep Technologies, Inc.Miami Lakes, FL, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Camedical Technology (cambodia) Co., Ltd.Samraong Takeo, CambodiaContract manufacturer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.Chengdu Sichuan, ChinaContract manufacturer, Manufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CMT Health Pte. Ltd.Singapore, SingaporeExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Comar, LLCBuena, NJ, United StatesContract manufacturer0000api.fda.gov
Cotronic Technology LimitedSHENZHEN, GUANG DONG PROVINCE Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal HealthNorfolk, NE, United StatesManufacturer0000api.fda.gov
Cardinal HealthDeland, FL, United StatesManufacturer0000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dongguan Yanxi Technology Co. Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Qing Xi Essentia Industries LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Entana LLCSavannah, GA, United StatesSpecification developer0000api.fda.gov
Excellent Medical Technology (thailand) Co., Ltd.U-Thai District Phra Nakhon Si Ayutthaya, ThailandContract manufacturer, Contract sterilizer0000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Eytan Import & DistributionModiin Central, IsraelManufacturer0000api.fda.gov
EmCyte CorporationFort Myers, FL, United StatesManufacturer0000api.fda.gov
Essentia Industries Ltd.Dong Guan Guangdong, ChinaManufacturer0000api.fda.gov
Fesun Shanghai Co., Ltd.shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
FIRSTAR HEALTHCARE Company Limited (Guangzhou)Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Foshan City Shunde Jiajun Plastic & Hardware Products Co LtdFoshan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G-5 Florida LLCJax, FL, United StatesContract manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd. (wuxi)Wuxi Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Greatcare 4u Sdn BhdSelangor Darul Ehsan, MalaysiaManufacturer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangdong Kindly Medical Device Group Co., LtdZhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Guangzhou Baoli Hardware & Electronic Co.,ltd.Guangzhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Guangdong Okay Technology Co.,Ltd.Zhong Shan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Henan Aile Industrial Co., Ltd.zhengzhou Henan, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hipp Praezisionstechnik GMBHKolbingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HK Surgical, Inc.San Clemente, CA, United StatesSpecification developer0000api.fda.gov
HLB Life Science Co., Ltd.Anseong-si, Gyeonggi-do, South KoreaManufacturer0000api.fda.gov
Hospitech RespirationLod Central IL, IsraelManufacturer0000api.fda.gov
Huana Technology (thailand) Co., Ltd.Bang Pakong Chachoengsao, ThailandManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Primecare Medical Co.,Ltd.hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Inmed (wuxi) Medical Device Co.,ltdWuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Kangbao Medical Equipment Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Micsafe Medical Technology Co., LtdYancheng Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.Shuyang Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangyin Nanquan Macromolecule Product Co., Ltd.JIANGYIN Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jinhua Jingdi Medical Supplies Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jumin Bio-Technologies, Co., LtdFengxian District Shanghai, ChinaContract manufacturer0000api.fda.gov
JWD. Technologies (jiangmen) Co.,ltd.Jiangmen Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kasem International Company Ltd.Samut Sakhon, ThailandContract manufacturer0000api.fda.gov
Koo Medical Equipment (shanghai) Co. Ltd.Songjiang Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Koo (Shanghai) Industries Co., LtdSongjiang Shanghai, ChinaManufacturer0000api.fda.gov
Laerdal Medical (suzhou) Co., Ltd.215009 Suzhou Jiangsu Province, ChinaManufacturer0000api.fda.gov
Lian Xin Toys LtdDongGuan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Lianyungang Aoke Medical Equipment Co.,ltd.Lianyungang Jiangsu, ChinaManufacturer0000api.fda.gov
Lifelong Meditech Private LimitedGurugram Haryana, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Linhai Deyi Plastic Co., LtdLinhai City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Luv N' Care, Ltd.Monroe, LA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mallinckrodt Hospital Products, Inc.Hazelwood, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Medico Industries & Trade Co., Ltd.SHIJIAZHUANG Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Meditec Technology Company LimitedBac Ninh, VietnamContract manufacturer, Contract sterilizer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0020api.fda.gov
Medmoldskarachi Sindh, PakistanContract manufacturer0000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medxl IncPointe-Claire Quebec, CanadaContract manufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Mida Precision Mold CorporationMy Yen Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA CellmyxCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Monitex Industrial Co., Ltd.SAN-CHUNG CITY Taipei, TaiwanManufacturer0000api.fda.gov
Munchkin Inc.Van Nuys, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medbio Orchard ParkOrchard Park, NY, United StatesContract manufacturer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Nanning Sixtant Biotechnology Co., LtdNanning Guangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer0000api.fda.gov
Ningbo Albert Novosino Co., Ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Yingmed Medical Instruments Co.,ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Nupur TechnologiesBuffalo, NY, United StatesManufacturer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Promisemed Hangzhou Meditech Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
PT. Jayamas Medica Industri TbkSidoarjo Jawa Timur, IndonesiaContract manufacturer, Contract sterilizer0000api.fda.gov
Pulsecare Medical, LLC.Plaistow, NH, United StatesManufacturer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Primecare Medical (Suzhou) Co.,Ltd.Changshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Recibio, Inc.Richmond, TX, United StatesSpecification developer0000api.fda.gov
Rhinosystems, Inc.Brooklyn, OH, United StatesSpecification developer0000api.fda.gov
Ribbel International Ltd.SONEPAT Haryana, IndiaManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Set Medikal Sanayi Ve Ticaret Anonim Sirketiesenyurt Istanbul, TurkeyManufacturer, Repackager or relabeler0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Huihu Medical Appliance Co. Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shantou Wealy Medical Instrument Co., Ltd.SHANTOU Guangdong, ChinaManufacturer0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Shenzhen Baria Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mlikang Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shun Sze Industrial (shenzhen) Co., LtdSHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Singgao Precision Technology (dongguan) Co., LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Splash Medical Devices, LLCAtlanta, GA, United StatesSpecification developer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaRepackager or relabeler, Specification developer0000api.fda.gov
SSN SolutionsHenrico, VA, United StatesSpecification developer0000api.fda.gov
Suministros Y Desechables Skkyd S.A. De C.V.Naucalpan Estado de Mexico, MexicoExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesManufacturer0010api.fda.gov
Sunmed Ap, Ltd.ZHUHAI Guangdong, ChinaContract manufacturer0000api.fda.gov
Surgin Surgical Instrumentation, Inc.Scottsdale, AZ, United StatesSpecification developer0000api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Jinsheng Plastic Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Pipi Medical Products Co.,ltdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Shanghai Xodus Medical Company LimitedShanghai, ChinaManufacturer0000api.fda.gov
Small Beginnings Inc.Hesperia, CA, United StatesSpecification developer0000api.fda.gov
Smart Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Sol-Millennium Medical, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Syntech Development & ManufacturingChino, CA, United StatesContract manufacturer0000api.fda.gov
Syrma Johari MedTech LimitedJodhpur Rajasthan, IndiaContract manufacturer0000api.fda.gov
Tai-Shiny Technology Co., Ltd.Guishan District Taoyuan, TaiwanManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tee-Zed Products, LLCGreensboro, NC, United StatesSpecification developer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesContract manufacturer0000api.fda.gov
Tools For Surgery, LLCStony Brook, NY, United StatesManufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesManufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Think Green LimitedKumeu Auckland, New ZealandManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Vastrade Manufacturing CorporationShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Vietnam Medical Plastic JSCTam Diep Ward Ninh Binh, VietnamContract manufacturer0000api.fda.gov
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,LtdWeihai Shandong, ChinaManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Xiamen Jieboya Technology Co.ltdXiamen Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiamen Longzhiyuan Plastic Co., LtdXiamen City Fujian, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer0000api.fda.gov
Yangzhou Medline Industry Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zhejiang Aicor Medical Technology Co., Ltd.Linhai Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Hope Pharma LtdWenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZHEJIANG LONGDE PHARMACEUTICAL Co., LtdHANGZHOU Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhuhai Longtime Biological Technology Co., Ltd.Zhuhai City Guangdong, ChinaManufacturer0000api.fda.gov
Zeek Medical Devices, LLCDoral, FL, United StatesManufacturer for export0000api.fda.gov

Updated November 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.