Bur, Dental (EJL): 183 FDA-registered makers in 23 countries

Name: FDA-registered makers of Bur, Dental
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

183 establishments in 23 countries are registered with the FDA to make Bur, Dental (product code EJL, Class 1, 21 CFR 872.3240). 2 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on June 20, 2008, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: EJL
Device class: 1
Regulation: 872.3240
Medical specialty: Dental

Makers by country

Country	Makers
China	44
United States	38
Germany	23
South Korea	14
Switzerland	12
Israel	9
Pakistan	7
Italy	5
India	4
Japan	4
Brazil	3
Canada	3
Taiwan	3
Spain	2
Thailand	2
Sweden	2
Ireland	2
Liechtenstein	1
Russia	1
Vietnam	1
Mexico	1
United Kingdom	1
Poland	1

Makers of Bur, 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.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
B.T.I. Biotechnology Institute, S.L.	Miñano Alava, Spain	Manufacturer, Specification developer	1	August 3, 2006	0	api.fda.gov
Gebr. Brasseler GMBH & Co. KG	LEMGO North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	1	June 29, 2007	0	api.fda.gov
3R Industria E Comercio Ltda	Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Abracadabra Implants Ltd.	Or Yehuda Central, Israel	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Accumedix, Inc.	Libertyville, IL, United States	Contract manufacturer	0		0	api.fda.gov
ACH Medical Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
ACURATA GMBH & CO. KGaA	Thurmansbang Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Adin Dental Implant Systems Ltd.	Afula Northern, Israel	Manufacturer	0		0	api.fda.gov
Altatec GMBH	WIMSHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
American Eagle Instruments	Missoula, MT, United States	Contract manufacturer	0		0	api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltd	Anqing City Anhui, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Arnold Tuber Industries	Orchard Park, NY, United States	Manufacturer	0		0	api.fda.gov
B&L Biotech Co., Inc	Ansan City Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Beyes Dental Inc	Toronto Ontario, Canada	Manufacturer	0		0	api.fda.gov
Bicon, LLC	Boston, MA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Bioline Dental Implant Systems Ltd	Migdal Tefen Northern, Israel	Manufacturer	0		0	api.fda.gov
Biomaterials Korea Inc.	Hanam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		1	api.fda.gov
Buffalo Dental MFG. Co., Inc.	Syosset, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
BUSCH & CO. GmbH & Co. KG	ENGELSKIRCHEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Basic Dental Implant Systems, Inc.	Rio Rancho, NM, United States	Manufacturer	0		0	api.fda.gov
CAMLOG Biotechnologies GmbH	Basel Basel-Stadt, Switzerland	Exporter to the US, Specification developer	0		0	api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou Hebei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
CDM Center Of Excellence Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Cendres+metaux SA	Biel/Bienne Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Changsha Nice Medical Instrument Limited Company	Changsha Hunan, China	Manufacturer	0		0	api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.	Chengdu Sichuan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Coltene/Whaledent AG	ALTSTAETTEN Sankt Gallen, Switzerland	Manufacturer	0		1	api.fda.gov
Coltene/Whaledent Inc.	Cuyahoga Falls, OH, United States	Contract manufacturer, Manufacturer	0		2	api.fda.gov
Crosstech Diamond Tools Co., Ltd.	Samutprakran Samut Prakan, Thailand	Manufacturer	0		0	api.fda.gov
Ctc(india) Private Limited	Jamshedpur Jharkhand, India	Manufacturer	0		0	api.fda.gov
Cynosure, LLC	Westford, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
CeramTec Schweiz GmbH	Spreitenbach Aargau, Switzerland	Manufacturer	0		0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Den-Mat Holdings, LLC	Lompoc, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Dent4you AG	Heerbrugg Sankt Gallen, Switzerland	Specification developer	0		0	api.fda.gov
Dentatus AB	SPANGA Stockholm, Sweden	Manufacturer	0		0	api.fda.gov
Dentech Corp.	Tokyo, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Dentin Implants Technologies Ltd.	Mizpe Aviv Northern, Israel	Manufacturer, Specification developer	0		0	api.fda.gov
Devemed GMBH	NEUHAUSEN OB ECK Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Dfs-Diamon GMBH	RIEDENBURG Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Dhef Inc.	New Taipei City, Taiwan	Manufacturer	0		0	api.fda.gov
Diaswiss S.A.	NYON Vaud, Switzerland	Manufacturer	0		0	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	Manufacturer	0		0	api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBH	Hamburg, Germany	Manufacturer	0		0	api.fda.gov
Dongguan Integrity Medical Instrument Co.,ltd.	Dongguan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Dongguan Wanjin Industrial Co., Ltd	DongGuang Guangdong, China	Remanufacturer	0		0	api.fda.gov
DR. Hopf GMBH & Co. KG	LANGENHAGEN Lower Saxony, Germany	Manufacturer	0		0	api.fda.gov
Dedeco International, Inc.	Long Eddy, NY, United States	Manufacturer	0		0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
E. C. Moore Company, Inc.	Dearborn, MI, United States	Manufacturer	0		0	api.fda.gov
Edenta Etablissement	SCHAANWALD Mauren, Liechtenstein	Manufacturer	0		0	api.fda.gov
Esthetic Orthodontic Company Of America LLC	St Petersburg, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Evidence Implant Inc.	Daegu, South Korea	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Funing Meitedental Factory	Yancheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
Gaofeng Medical Equipment (wuxi) Co., Ltd	Wuxi city Jiangsu, China	Manufacturer	0		0	api.fda.gov
Garish Apparels	Wazirabad Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
GENOSS Co., Ltd.	Suwon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangdong Rotary Art Equipment Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		0	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	0		2	api.fda.gov
Hager & Werken GMBH	DUISBURG,DE-NOTA Hamburg, Germany	Manufacturer	0		0	api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Hans Korea	Paju-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Hefei Mlush Sanitary Products Co.,ltd	Hefei Anhui, China	Manufacturer	0		0	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hi Tec Implants, Ltd.	HERZLIA Tel Aviv, Israel	Manufacturer	0		0	api.fda.gov
Hopf, Ringleb & Co. GMBH & Cie.	Berlin, Germany	Manufacturer	0		0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Manufacturer	0		0	api.fda.gov
Hufschmied Zerspanungssysteme GMBH	Bobingen Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Henan Lusterdent Medical Instrument Co.,Ltd	Zhengzhou Henan, China	Manufacturer	0		0	api.fda.gov
Icp, Inc.	Green Bay, WI, United States	Specification developer	0		0	api.fda.gov
Institut Straumann AG	BASEL Basel-Stadt, Switzerland	Specification developer	0		0	api.fda.gov
Jining Orodeka Medical Equipment Co.,ltd	JiNing Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltd	Tianjin, China	Manufacturer	0		0	api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, Brazil	Manufacturer	0		1	api.fda.gov
Jota AG	RUETHI, SG Sankt Gallen, Switzerland	Contract manufacturer	0		0	api.fda.gov
Kazan Medical Instruments Plant	Kazan Tatarstan, Russia	Manufacturer	0		0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	0		0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	0		0	api.fda.gov
Kerr Italia, S.r.l.	SCAFATI Salerno, Italy	Manufacturer	0		0	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer	0		0	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Mani, Inc. (head Office)	UTSUNOMIYA Tochigi, Japan	Manufacturer	0		0	api.fda.gov
Mani, Inc. (takanezawa Facility)	SHIOYA Tochigi, Japan	Contract manufacturer	0		0	api.fda.gov
MDT Micro Diamond Technologies Ltd	AFULA Northern, Israel	Manufacturer	0		0	api.fda.gov
Medcave Private Limited	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
MEDESY srl	MANIAGO Pordenone, Italy	Manufacturer	0		0	api.fda.gov
Medimecca Co Ltd	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Micerium S.P.A.	AVEGNO Genova, Italy	Manufacturer	0		0	api.fda.gov
Microcopy, Division Of Neo-Flo, Inc.	Kennesaw, GA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Mothers Medica Private Limited	Chennai Tamil Nadu, India	Manufacturer	0		0	api.fda.gov
Muller India Private Limited	GURGAON Haryana, India	Manufacturer	0		0	api.fda.gov
Mani Hanoi Co. Ltd	Thai Nguyen Province, Vietnam	Contract manufacturer	0		0	api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)	Daegu, South Korea	Specification developer	0		0	api.fda.gov
Megagen Implant Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Nextcon International	Sialkot Punjab, Pakistan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Ningbo Sinyuan Bur & Tool Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
Nobel Biocare Procera, LLC	Mahwah, NJ, United States	Contract manufacturer	0		0	api.fda.gov
North Bel Intl. SRL.	PADERNO DUGNANO Milano, Italy	Manufacturer	0		0	api.fda.gov
Nova Implants Ltd	Or-Yehuda Tel Aviv, Israel	Specification developer	0		0	api.fda.gov
Nti-Kahla GMBH, Rotary Dental Instruments	KAHLA Thuringia, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Onvet Medical Canada Inc	TORONTO Ontario, Canada	Manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.	Marilia Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Osstem Implant Co., Ltd.	Gangseo-gu Seoul, South Korea	Specification developer	0		0	api.fda.gov
Osstem Implant Co., Ltd.	Haeundae-gu Busan, South Korea	Manufacturer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer	0		0	api.fda.gov
Osung MND Co., Ltd.	Gimpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Ot Medical GMBH	Bremen, Germany	Manufacturer	0		0	api.fda.gov
Otto Leibinger GMBH	MUEHLHEIM Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	0		0	api.fda.gov
Paltop Advanced Dental Solutions Ltd	Caesarea Central, Israel	Contract manufacturer	0		0	api.fda.gov
Pengbo (shenzhen) Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Manufacturer for export	0		0	api.fda.gov
Prima Dental Group	GLOUCESTER Gloucestershire, United Kingdom	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
PSM Medical GmbH	Gunningen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Puracon GMBH	Rosenheim Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Power Dental USA, Inc.	McHenry, IL, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Reco-Dent Intl. Co., Ltd.	New Taipei City, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Reliance Orthodontic Products, Inc.	Itasca, IL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Rolence Ent. Inc.	CHUNGLI Taoyuan, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
SDS Swiss Dental Solutions	Kreuzlingen Thurgau, Switzerland	Specification developer	0		0	api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., Ltd	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Fanta Dental Materials Co., Ltd.	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Lions Industrial Co.,ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shanghai Shofu Dental Material Co. Ltd	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shanghai Smedent Medical Instrument Co., Ltd	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen Forever Medical Devices Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen Jinzhou Precision Technology Corp.	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Yurucheng Dental Materials Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shofu Inc.	FUKUINE, HIGASHIYAMA-KU Kyoto, Japan	Manufacturer	0		0	api.fda.gov
Sicat GMBH & Co. KG	BONN North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Sino Ortho Limited	HANGZHOU Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Sinyuan Dental (thailand) Co.,ltd.	Pluakdaeng District Rayong, Thailand	Manufacturer	0		0	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sphinx Tools Ltd	Derendingen Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
SS White Burs LLC	Lakewood, NJ, United States	Manufacturer	0		0	api.fda.gov
Storz Am Mark GMBH	EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Stryker Ireland Ltd., Instruments Division	CARRIGTWOHILL, CO.CORK Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Surgident Co., Ltd.	Dong-gu Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Shaanxi Hanrui Med-Tech Co., Ltd.	Hanzhong Shaanxi, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shanghai Toboom Dental Techonology CO., LTD.	Shanghai, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Solventum Germany GmbH	SEEFELD Bavaria, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Straumann Villeret SA	VILLERET Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Strauss & Co.	Raanana Central, Israel	Manufacturer	0		0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork(County), Ireland	Specification developer	0		0	api.fda.gov
Taizhou Proburrs Medical Technology Co., Ltd.	Taizhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
TF New Material Sci And Tec Co.,ltd	Huainan Anhui, China	Manufacturer	0		0	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	0		0	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
TruAbutment Korea Co., Ltd.	Bucheon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Ustomed Instrumente GMBH & Co. KG	Tuttlingen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Ultradent Products Inc.	South Jordan, UT, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Verdent Ltd.	LODZ Lodzkie, Poland	Manufacturer	0		0	api.fda.gov
Versah LLC	Jackson, MI, United States	Manufacturer	0		0	api.fda.gov
Versah, LLC	Jackson, MI, United States	Manufacturer	0		0	api.fda.gov
WILSON (Shanghai) Medical Device Co., Ltd	Shanghai, China	Manufacturer	0		0	api.fda.gov
Win Wings Corp.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	0		0	api.fda.gov
Xenopus Inc.	Morrisburg Ontario, Canada	Manufacturer	0		0	api.fda.gov
Zain's Medical Image	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Zentro Enterprise Pvt Ltd	RAJKOT Gujarat, India	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ziacom Implants Slu	Pinto Madrid(Province), Spain	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Zonefly Medical Devices Co., Ltd.	Danyang Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Zuga Medical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	Manufacturer for export	0		0	api.fda.gov

Updated June 20, 2008. 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.