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.
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
- MNK
- Device class
- 1
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 35 |
| United States | 26 |
| Japan | 9 |
| Mexico | 5 |
| United Kingdom | 3 |
| Canada | 2 |
| Taiwan | 2 |
| Hong Kong | 2 |
| Germany | 2 |
| South Korea | 2 |
| India | 1 |
| Vietnam | 1 |
| Pakistan | 1 |
| Poland | 1 |
| Italy | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gi Supply | Mechanicsburg, PA, United States | Manufacturer | 1 | October 4, 1993 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Algram Group Ltd | Plymouth Devon, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices Pvt. Ltd. | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anrei Medical (Hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Batrik Medical Manufacturing Inc. | Lachine Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Johns Creek, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Health Microport Medical Device Co.,ltd. | Changzhou Jiangsu, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | CHANGZHOU Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Batavia, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Choice LLC | Greensboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 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 | 0 | 0 | api.fda.gov | |
| Diversatek Healthcare Inc | Milwaukee, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Diagnostics Incorporated | Plymouth, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversatek Vietnam Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enter Medical Corporation | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ga Health Company Limited | Hong Kong, Hong Kong | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gerui Medical Products Co Ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H.+H. Maslanka Chirurgische Instrumente GmbH | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Stellarmed Medical Technology Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Weize Imp & Exp Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Nuri Co., Ltd. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Bo (hu Bei) Medical Products Co., Ltd | DuPu Town, Jia Yu County, Xianning City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inoris Medical SP. Z O.O. | Kowary Dolnoslaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventeur, LLC | Saint Petersburg, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Grit Medical Technology Co., Ltd. | changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | Ji 'an Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KEYMED (Medical & Industrial Equipment) Ltd | SOUTHEND-ON-SEA Essex, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kruse Tool & Die, Inc. | Warminster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditalia S.R.L.. | Palermo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nadia-Health Inc | Durham, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nasorcap Medical, Inc. | Venetia, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newtrans International Company | Nashville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Boya Medical Equipment Co.,ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeVap Inc Inventory Management | San Jose, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omnimate Enterprise Co., Ltd. | Ilan County Yilan, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optimedi Co., Ltd. | Goyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pneumocyte LLC ( Thoracic Innovations - A Dba Of Pneumocyte) | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qidong Yongsheng Medical Products Factory | Qidong City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rci Hudson De Mexico S. De RL. De CV. | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartdata Suzhou Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SML Med-Tech Solutions Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jinsheng Plastic Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Suning Underpad Co., Ltd. | Suzhou, Jiangsu Province, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Civac Mexico, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. de C.V | Jiutepec Morelos, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Lethean Company, LLC | Chester Sprgs, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tribest Dental Products Co Ltd | Yangzhong Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Sterile, Inc. | Salisbury, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Caretek Medical Device Co., Ltd | Wenzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilson Instruments (sha) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weco Manufacturing Group-Henrietta | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welmed, Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Chuangyou Science & Technology Development Co., Ltd. | Yangzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuyao Guangjing Medical Instrument Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Soudon Medical Technology Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuji Pengtian Medical Instrument Co.,Ltd. | Zhuji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.