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Data / Medical devices / Endoscopic Bite Block

Endoscopic Bite Block (MNK): 93 FDA-registered makers in 15 countries

93 establishments in 15 countries are registered with the FDA to make Endoscopic Bite Block (product code MNK, Class 1, 21 CFR 876.1500). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 11, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MNK
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
China35
United States26
Japan9
Mexico5
United Kingdom3
Canada2
Taiwan2
Hong Kong2
Germany2
South Korea2
India1
Vietnam1
Pakistan1
Poland1
Italy1

Makers of Endoscopic Bite Block

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
Gi SupplyMechanicsburg, PA, United StatesManufacturer1October 4, 1993000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer0000api.fda.gov
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaManufacturer0000api.fda.gov
Algram Group LtdPlymouth Devon, United KingdomManufacturer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Batrik Medical Manufacturing Inc.Lachine Quebec, CanadaManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationJohns Creek, GA, United StatesManufacturer0000api.fda.gov
Changzhou Endoclean Medical Device Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Health Microport Medical Device Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer0000api.fda.gov
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Jiuhong Medical Instrument Co., Ltd.CHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Cordica Medical, Inc.Batavia, IL, United StatesContract manufacturer0000api.fda.gov
Clinical Choice LLCGreensboro, NC, United StatesSpecification developer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.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
Diversatek Healthcare IncMilwaukee, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Dynamic Diagnostics IncorporatedPlymouth, MI, United StatesSpecification developer0000api.fda.gov
Diversatek Vietnam Company LimitedHo Chi Minh City, VietnamContract manufacturer0000api.fda.gov
Enter Medical CorporationChiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanSpecification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Ga Health Company LimitedHong Kong, Hong KongComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Gerui Medical Products Co LtdChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
H.+H. Maslanka Chirurgische Instrumente GmbHTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hangzhou Stellarmed Medical Technology Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Health Nuri Co., Ltd.Yeongdeungpo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Hong Bo (hu Bei) Medical Products Co., LtdDuPu Town, Jia Yu County, Xianning City Hubei, ChinaManufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Inoris Medical SP. Z O.O.Kowary Dolnoslaskie, PolandManufacturer0000api.fda.gov
Inventeur, LLCSaint Petersburg, FL, United StatesSpecification developer0000api.fda.gov
Jiangsu Grit Medical Technology Co., Ltd.changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Power-Endo Medical Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.Ji 'an Jiangxi, ChinaManufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
KEYMED (Medical & Industrial Equipment) LtdSOUTHEND-ON-SEA Essex, United KingdomSpecification developer0000api.fda.gov
Kruse Tool & Die, Inc.Warminster, PA, United StatesContract manufacturer0000api.fda.gov
Meditalia S.R.L..Palermo, ItalyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Nadia-Health IncDurham, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nasorcap Medical, Inc.Venetia, PA, United StatesManufacturer0000api.fda.gov
Newtrans International CompanyNashville, TN, United StatesSpecification developer0000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer0000api.fda.gov
Ningbo Boya Medical Equipment Co.,ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
NeVap Inc Inventory ManagementSan Jose, CA, United StatesSpecification developer0000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Omnimate Enterprise Co., Ltd.Ilan County Yilan, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Optimedi Co., Ltd.Goyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Pneumocyte LLC ( Thoracic Innovations - A Dba Of Pneumocyte)Durham, NC, United StatesSpecification developer0000api.fda.gov
Qidong Yongsheng Medical Products FactoryQidong City Jiangsu, ChinaManufacturer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Smartdata Suzhou Co., LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
SML Med-Tech Solutions LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Southmedic, Inc.BARRIE Ontario, CanadaManufacturer0000api.fda.gov
Suzhou Jinsheng Plastic Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Suning Underpad Co., Ltd.Suzhou, Jiangsu Province, ChinaContract manufacturer0000api.fda.gov
Sion Biotext Mexico, S.A.P.I. De C.V.Civac Mexico, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Sion Biotext Mexico, S.A.P.I. de C.VJiutepec Morelos, MexicoContract manufacturer, Manufacturer0000api.fda.gov
The Lethean Company, LLCChester Sprgs, PA, United StatesManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer0000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer0000api.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
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Wenzhou Caretek Medical Device Co., LtdWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Wilson Instruments (sha) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Yangzhou Chuangyou Science & Technology Development Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yuyao Guangjing Medical Instrument Co.,ltdNingbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Soudon Medical Technology Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhuji Pengtian Medical Instrument Co.,Ltd.Zhuji Zhejiang, ChinaManufacturer0000api.fda.gov

Updated October 11, 1994. 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.