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Data / Medical devices / Handle, Instrument, Dental

Handle, Instrument, Dental (EJB): 213 FDA-registered makers in 23 countries

213 establishments in 23 countries are registered with the FDA to make Handle, Instrument, Dental (product code EJB, Class 1, 21 CFR 872.4565). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on July 8, 2014, and lists 1 recall event (0 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
EJB
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan59
United States47
China28
Germany17
South Korea13
Italy6
Brazil5
Switzerland4
Sweden4
Israel3
Taiwan3
France3
India3
Malaysia3
United Kingdom3
Spain2
Denmark2
Japan2
Russia2
Australia1
Finland1
Canada1
Hong Kong1

Makers of Handle, Instrument, 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
Centrix, Inc.Shelton, CT, United StatesContract manufacturer, Manufacturer1July 8, 2014000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Specification developer1July 8, 2014000api.fda.gov
A Fone SurgicoSialkot Punjab, PakistanManufacturer0000api.fda.gov
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
A.B. Dental Devices LtdAshdod Southern, IsraelManufacturer0000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Aditek Do Brasil, SACRAVINHOS Sao Paulo, BrazilManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Alliance Global Technology Co., Ltd.Kaohsiung, TaiwanManufacturer0000api.fda.gov
ALVI ExpoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Amedcon Medical Technology (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
American Eagle InstrumentsMissoula, MT, United StatesManufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer0000api.fda.gov
Armatech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Aseptico, Inc.Woodinville, WA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
ATRIA Co.Seoul, South KoreaManufacturer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
B&L Biotech Co., IncAnsan City Gyeonggi, South KoreaManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
B.T.I. Biotechnology Institute, S.L.Miñano Alava, SpainExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Biomaterials Korea Inc.Hanam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer0000api.fda.gov
Basic Dental Implant Systems, Inc.Rio Rancho, NM, United StatesManufacturer0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Biopsy Fine Cut InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Chung Song Industrial Co.YONGIN-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Coda Resources Ltd., Heze ChinaHeze, Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Concise EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Contech Holdings LLCBrea, CA, United StatesContract manufacturer0000api.fda.gov
Creative Dental Concepts LLCBirmingham, MI, United StatesManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Curaden AGKriens Luzern, SwitzerlandExporter to the US, Specification developer0000api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
D B Orthodontics LtdWEST YORKSHIRE England, United KingdomComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Daekwang I.D.MSeoul, South KoreaManufacturer0000api.fda.gov
Darleys Surgical Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Den Tag S.R.L.MANIAGO, PN. Pordenone, ItalyManufacturer0000api.fda.gov
Densol International (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenExporter to the US, Manufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
E. Hahnenkratt GMBHKOENIGSBACH-STEIN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ergodenta ApsTaastrup Hovedstaden, DenmarkContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Erskine DentalMACKSVILLE New South Wales, AustraliaExporter to the US, Specification developer0000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Evidence Implant Inc.Daegu, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Forward Science Technologies LLCHouston, TX, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G.A. Surgical (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Goldman Products, Inc.Wauconda, IL, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
GoldenDentRoseville, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Herd Star Company, Inc.Dauphin, PA, United StatesManufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hilbro Instruments (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hospimed MFGSialkot Punjab, PakistanManufacturer0000api.fda.gov
Hu-Friedy MFG Co., LLCDes Plaines, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer0000api.fda.gov
Implant Protesis Dental 2004, S.L.Premia de Dalt Barcelona, SpainManufacturer0000api.fda.gov
Indusbello Industria De Instrumentos OdoLondrina Parana, BrazilManufacturer0000api.fda.gov
Industria Zingardi S.R.LNovi Ligure Piedmont, ItalySpecification developer0000api.fda.gov
Infirmary Medical SuppliesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Innobiosurg Co., Ltd.Daejeon, South KoreaManufacturer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Itena Clinical VillepinteVillepinte Seine-Saint-Denis, FranceSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd.Jiangmen, Guangdong, ChinaManufacturer0000api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltdTianjin, ChinaManufacturer0000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer0000api.fda.gov
Kazan Medical Instruments Plant Joint Stock CompanKAZAN Tatarstan, RussiaManufacturer0000api.fda.gov
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin Malaysia Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
La.sc.od. SPAFLORENCE, TUSCANY Firenze, ItalyManufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Lm-Instruments OYPARAINEN Varsinais-Suomi, FinlandManufacturer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
MC Bio S.R.L.Lomazzo Como, ItalyManufacturer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Medical Systems And Devices International Ltd.Kiryat Ata Haifa, IsraelComplaint file establishment, Specification developer0000api.fda.gov
Medisporex (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Metro MedicalSialkot Punjab, PakistanManufacturer, Repackager or relabeler0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer0000api.fda.gov
Miing Wei Co., Ltd.Tsao-Twon Nantou, TaiwanContract manufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Nadir & Co.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Nawaz And SonsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Neoss ABGoteborg Vastra Gotaland, SwedenManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Nobil-Metal S P AVillafranca Dasti, ItalyManufacturer0000api.fda.gov
Nordent MFG., Inc.Elk Grove Village, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
NR Surgical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Nova InstrumentsBerkshire Wokingham, United KingdomContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Oertel Medical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orthopli Corp.Philadelphia, PA, United StatesManufacturer0000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Osteogenics Biomedical, Inc.Lubbock, TX, United StatesManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ot Medical GMBHBremen, GermanyManufacturer0000api.fda.gov
Otto Leibinger GMBHMUEHLHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paltop Advanced Dental Solutions LtdCaesarea Central, IsraelManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
PDT, Inc.Msla, MT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Prodont-Holliger S.A.S.OLLIERGUES Puy-de-Dome, FranceManufacturer0000api.fda.gov
Pru-Dent MFG., Inc.Schaumburg, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
PSM Medical GmbHGunningen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Premium Plus International LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Ronvig Dental MFG. A/SDAUGAARD Midtjylland, DenmarkManufacturer0000api.fda.gov
Sabokay IndustriesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Saeshin Precision Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Sanctuary Health Sdn BhdChemor Perak, MalaysiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Shanghai Fanta Dental Materials Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Shanwei Perfect Medical Instruments Co.,ltd.Shanwei Guangdong, ChinaManufacturer0000api.fda.gov
Shengiho Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shurcon Manufacturing CompanyJia Shan Zhejiang, ChinaManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Specialized Care Co IncHampton, NH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgikareSIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
Suzhou Ramo Medical Instrument Co., Ltd.Suzhou City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Svenska Dentorama ABSOLLENTUNA Stockholm, SwedenManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Meijiante Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shinhung MST Co., Ltd.Wonju Si Gangwon, South KoreaManufacturer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
TDV Dental LtdaPOMERODE Santa Catarina, BrazilContract manufacturer, Manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Thommen Medical, AGGRENCHEN Solothurn, SwitzerlandManufacturer0000api.fda.gov
Tor VM Ltd.Moscow Moskva, RussiaManufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Winning Appliance Manufactory LimitedCHAI WAN HONG KONG Xinjiang, ChinaManufacturer0000api.fda.gov
Wise InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Y. Z. CorporationSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Ydm CorporationHIGASHIMATSUYAMA-SHI Saitama, JapanManufacturer0000api.fda.gov
Young Microbrush LLCGrafton, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zentro Enterprise Pvt LtdRAJKOT Gujarat, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Zirc Dental Products, Inc.Buffalo, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated July 8, 2014. 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.