Data / Medical devices / Tourniquet, Nonpneumatic
Tourniquet, Nonpneumatic (GAX): 235 FDA-registered makers in 22 countries
235 establishments in 22 countries are registered with the FDA to make Tourniquet, Nonpneumatic (product code GAX, Class 1, 21 CFR 878.5900). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on September 1, 1993, and lists 4 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
- GAX
- Device class
- 1
- Regulation
- 878.5900
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 106 |
| United States | 66 |
| Taiwan | 8 |
| India | 8 |
| Mexico | 7 |
| United Kingdom | 6 |
| Israel | 6 |
| Germany | 5 |
| Malaysia | 5 |
| Pakistan | 3 |
| Dominican Republic | 3 |
| Thailand | 2 |
| Canada | 1 |
| Chile | 1 |
| Italy | 1 |
| Austria | 1 |
| Guatemala | 1 |
| Sweden | 1 |
| Honduras | 1 |
| Sri Lanka | 1 |
| Ukraine | 1 |
| France | 1 |
Makers of Tourniquet, Nonpneumatic
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 |
|---|---|---|---|---|---|---|---|---|
| MAR-MED Inc. | Grand Rapids, MI, United States | Manufacturer | 1 | October 10, 1985 | 0 | 1 | 0 | api.fda.gov |
| 3FDM, Inc. | Largo, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ablexan Corporation | Raleigh, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aero Healthcare | Valley Cottage, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agora Sales, Inc. | Saint Petersburg, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aike (shanghai) Medical Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alframed | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphapointe | Kansas City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Anshen Surgical Dressings Co., Ltd. | Huzhou, Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Hongde Medical Products Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anping Guardian Medical Equipment Co.,ltd | Hengshui Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Astute Choice Packaging | Henrico, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Caguas, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Action Packaging | Woodstock, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphapointe | Jamaica, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bestreat Safety & First Aid Solution Co., Ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Nuclear Diagnostics, Inc. | TORONTO Ontario, Canada | Exporter to the US, 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 | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bailey Instruments Ltd | Manchester, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C-A-T Resources LLC | Rock Hill, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chin Kou Medical Instrument Co.,ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Chino, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CORMED Ltd | Huddersfield Kirklees, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cro, LLC | Missoula, MT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degania Silicone, Ltd. | DEGANIA BET Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Distinctive Plastics, Inc. | Vista, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Distributed Medical Device Manufacturing LLC. | Tucson, AZ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Risen Medical Products Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongyang City Yonoel Outdoor Products Co.,ltd | Dongyang Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dvl-Op Medico Inc | Valencia, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dragon Medical Co.,Ltd | Suzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medtek(jiangsu) Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emg Technology Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emsrun Group | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Elastomer Solutions | KOCHI Kerala, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entrotech Life Sciences, LLC | Columbus, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exact Medical Manufacturing, Inc. | Changzhou Jiangsu, China | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exact Medical Manufacturing, Inc. | Changzhou Jiangsu, China | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Surgical, LLC | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Finix Industrial Co., Ltd. | Chang Hua City Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Care Products Ltd. | Rosh HaAyin Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FIRSTAR HEALTHCARE Company Limited (Guangzhou) | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flamor SRL | San Pietro Novara, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footprint Medical Inc. | San Antonio, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frogfish International Corp. | Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G Surgiwear Limited | Shahjahanpur Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Fulflex Usa, Inc. | Brattleboro, VT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Healthcare India Pvt Ltd | Satara Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauke (hubei) Healthcare Co., Ltd | Huanggang City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greiner Bio-One GMBH | KREMSMUENSTER Oberosterreich, Austria | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Improve Medical Instruments Co., Ltd. | Guangzhou Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Noval Medical Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Fulflex India Private Ltd (Formerly Garware Bestretch Ltd) | SATARA Maharashtra, India | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.) | Fort Worth, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Healthcare, SAS | Santiago de los Caballeros, Dominican Republic | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&K International Trade Limited (china) | jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hammarplast Medical AB | Lidkoping Vastra Gotaland, Sweden | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Aosi Healthcare Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. Ltd | Hangzhou City Zhejiang, China | 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 | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Runde Medical Instruments Co.,ltd | Hengshui City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 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 | |
| Harsoria Healthcare Pvt. Ltd. (Unit-2) | Baddi Himachal Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heaven Healthcare Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovate Medical Malaysia, Sdn. Bhd. | Shah Alam Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovate Medical, LLC | Johnson City, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovate Polimer Company | KOCHI Kerala, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itl Asia Pacific Sdn Bhd | Batu Gajah Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jcmed Tianjin Import And Export Co., Ltd | Tianjin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | YANGZHOU CITY, Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Qiantai Medical Instrument Co., Ltd. | Tai zhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiaxing Haines Textile Co.,ltd. | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen City Hubei, China | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jenius Medical Sci-Tech (Thailand) Co., Ltd. | Nong Yai District, Chon Buri, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hongsheng Bioengineering Co., Ltd. | Nantong Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JosNoe Medical Inc | Nixa, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Elastomer Products, Inc | Mogadore, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Elastomer Products, Inc. | Dundee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimetec GMBH | DITZINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kit Company | Phoenix, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Little Doctor Electronic(nantong) Co.,ltd | Nantong Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonjyfan Enterprise Corp. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Little Rapids Corporation | Green Bay, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manman Manufacturing Company Private Limited | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mayfair Industry Co., Ltd. | New Taipei City 220, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDF Instruments Medifriend Inc. | Song Jiang District, Shanghai, China | 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 | |
| Medsource Factory,inc. | CHANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medstar Healthcare Co.,limited | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marpel | Omer Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Asn Medical Technology Co.,ltd | NANJING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo First Import & Export Co., Ltd. | NINGBO Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Guangbo Medical Technology Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Jenius Polymer Sci-Tech Co., Ltd | YinZhou District, Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianbo First Aid Product Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yingmed Medical Instruments Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North American Rescue, LLC. | Greer, SC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OHK Medical Devices INC | Grandville, MI, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oneg HaKarmel LTD | Tirat Carmel Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasticoscrt, S.A. De C.V. | Santa Catarina Nuevo Leon, Mexico | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Devices, LLC | Thousand Oaks, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Propper MFG. Co., Inc. | Long Island City, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pain Care Labs | Atlanta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Latex Products (pvt) Ltd | hanwella Western, Sri Lanka | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qidong Yongsheng Medical Products Factory | Qidong City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RCR Medical Products, LLC | McKinney, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Revmedx, Inc. | Wilsonville, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robinson Healthcare Limited | Worksop Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Riester GMBH | JUNGINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ruian Sunnyworld International Trade Co.,ltd | RUIAN Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rusun Medical Co., Ltd | Yichun City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safecare Medical Products Co., Ltd. (hefei) | HEFEI Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safeguard Medical Technologies Ltd | Hereford Herefordshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safeguard Us Operating, LLC | Huntersville, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saferlife Products Co.,ltd. | Guangzhou Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sam Medical Products | Tualatin, OR, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Shandong Int Medical Instruments Co., Ltd | Rizhao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Jinlai Huanhai Medical Technology Co.,ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jini Rubber & Plastic Products Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hengdasheng Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shunde Lucas Industries | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sich Ua | Kyiv Kyyivs'ka Oblast', Ukraine | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Snakestaff Systems | South Salt Lake, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rongfeng Technology Co.,Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Small Beginnings Inc. | Hesperia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Meccan Import and Export Corp. | Suzhou Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tacmed Solutions, LLC | Anderson, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tactical Stitch | Sialkot Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taicend Technology Co., Ltd | Kaohsiung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hygenic Company, LLC | Akron, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transparent Supply Solutions Ltd. | Dover, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-Tech Forensics, Inc. | Leland, NC, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tuper Medical Co., Ltd. | Dezhou City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Texstrip Manufacturing SDN.BHD. | Darul Ehsan Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hygenic Corporation | Batu Gajah Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiantai Shengtengyun Medical Supplies Co., Ltd. | TIANTAI COUNTY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Timesco Healthcare Ltd | Basildon Essex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions Weobley Limited | Weobley Herefordshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Union Pioneer Public Co., Ltd | Bangkok Krung Thep Maha Nakhon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ustomed Instrumente GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Dragons Sdn. Bhd. | Melaka, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vistar Medical Supplies Co., Ltd. | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | 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 | |
| Wenzhou Dongfang Medical Instruments Co., Ltd | WENZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Longwan Medical Device Factory | Wenzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wheelstone Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waismed Ltd. | Rosh Haayin Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Shengkai Technology Industry Co.,Ltd | Wenzhou city Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Kaishun Medical Device Manufacturing Co., Ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Coson Medical Instruments Co., Ltd | Xiamen City Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xmetix Ltd | Nazareth Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Kebon Healthcare Co., Ltd. | Yiwu Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Xutai Outdoor Camping Products Co.,ltd | Yiwu Zhejiang, China | 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 | |
| Yiwu Ori-Power Medtech Co., Ltd. | YIWU Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Jiekang Medical Equipment Co.,ltd | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Banghaoning Medical Supplies Co., Ltd | YiWu Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Excellent United Medical Technology Co.,ltd | Jinhua Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Honsun Medical Technology Co., Ltd. | Wenzhou City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Renkang Medical Products Co., Ltd. | Jinhua city Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Xinwei Weaving Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Qichuang Medical Products Co.,ltd. | Zibo Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZJG Royaltrust Med Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. | ZHANGJIAGANG Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| m2 inc. | Camp Johnson, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 1, 1993. 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.