Data / Medical devices / Syringe, Irrigating (Non Dental)
Syringe, Irrigating (Non Dental) (KYZ): 226 FDA-registered makers in 24 countries
226 establishments in 24 countries are registered with the FDA to make Syringe, Irrigating (Non Dental) (product code KYZ, Class 1, 21 CFR 880.6960). 6 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on November 5, 2020, and lists 15 recall events (1 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
- KYZ
- Device class
- 1
- Regulation
- 880.6960
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 81 |
| United States | 72 |
| Germany | 20 |
| Pakistan | 11 |
| Mexico | 7 |
| India | 7 |
| Taiwan | 5 |
| Thailand | 3 |
| Vietnam | 3 |
| Canada | 2 |
| Israel | 2 |
| Dominican Republic | 1 |
| Switzerland | 1 |
| Ireland | 1 |
| Cambodia | 1 |
| Singapore | 1 |
| Malaysia | 1 |
| South Korea | 1 |
| Honduras | 1 |
| Indonesia | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
| Turkey | 1 |
| New Zealand | 1 |
Makers of Syringe, Irrigating (Non 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 | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Micromedics, Inc. | Saint Paul, MN, United States | Manufacturer | 3 | March 15, 2011 | 0 | 1 | 0 | api.fda.gov |
| Nordson MEDICAL Mexico | Guaymas Sonora, Mexico | Contract manufacturer, Exporter to the US | 2 | March 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 1 | February 17, 1981 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | June 7, 1993 | 0 | 3 | 0 | api.fda.gov |
| MAR-MED Inc. | Grand Rapids, MI, United States | Manufacturer | 1 | September 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Nurse Assist, LLC | Haltom City, TX, United States | Manufacturer | 1 | November 20, 1981 | 0 | 0 | 0 | api.fda.gov |
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aena Medical (jiangsu) Co.,ltd. | Jiangyin City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Albert Hohlkoerper GMBH & Co. KG | HEMER North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alger Technology Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Easyway Medical Supplies Co., Ltd | Tian Chang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Yixiang Trading Co., Ltd | Hefei Anhui, China | 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 | |
| Apothecary Products, LLC. | Burnsville, MN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asanus Medizintechnik GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asia Connection Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices Pvt. Ltd. | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical AG | ESCHOLZMATT Luzern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bashir Jamil & Brothers (pvt.), Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bauer Und Haselbarth-Chirurg GMBH | ELLERAU Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson And Company | Columbus, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Plastics Co. | Taicang, Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionix, LLC | Maumee, OH, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biorep Technologies, Inc. | Miami Lakes, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Camedical Technology (cambodia) Co., Ltd. | Samraong Takeo, Cambodia | Contract 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 | |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu Sichuan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CMT Health Pte. Ltd. | Singapore, Singapore | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comar, LLC | Buena, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cotronic Technology Limited | SHENZHEN, GUANG DONG PROVINCE Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Norfolk, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Deland, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yanxi Technology Co. Ltd. | Dongguan Guangdong, China | Manufacturer | 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 | |
| Dongguan Qing Xi Essentia Industries Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elmed Instruments (pvt). Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entana LLC | Savannah, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excellent Medical Technology (thailand) Co., Ltd. | U-Thai District Phra Nakhon Si Ayutthaya, Thailand | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exelint International, Co. | Redondo Beach, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eytan Import & Distribution | Modiin Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EmCyte Corporation | Fort Myers, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essentia Industries Ltd. | Dong Guan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fesun Shanghai Co., Ltd. | shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FIRSTAR HEALTHCARE Company Limited (Guangzhou) | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G-5 Florida LLC | Jax, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd. (wuxi) | Wuxi Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatcare 4u Sdn Bhd | Selangor Darul Ehsan, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Kindly Medical Device Group Co., Ltd | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Baoli Hardware & Electronic Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Okay Technology Co.,Ltd. | Zhong Shan Guangdong, China | Exporter to the US, 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 | |
| Henan Aile Industrial Co., Ltd. | zhengzhou Henan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henke-Sass Wolf, GMBH. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Praezisionstechnik GMBH | Kolbingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HK Surgical, Inc. | San Clemente, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HLB Life Science Co., Ltd. | Anseong-si, Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Respiration | Lod Central IL, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huana Technology (thailand) Co., Ltd. | Bang Pakong Chachoengsao, Thailand | 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 | |
| Hangzhou Primecare Medical Co.,Ltd. | hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inmed (wuxi) Medical Device Co.,ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intl. Medsurg Connection, Inc. | Schaumburg, IL, United States | Specification developer | 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 | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Instruments, LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangbao Medical Equipment Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Micsafe Medical Technology Co., Ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Nanquan Macromolecule Product Co., Ltd. | JIANGYIN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jumin Bio-Technologies, Co., Ltd | Fengxian District Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JWD. Technologies (jiangmen) Co.,ltd. | Jiangmen Guangdong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kasem International Company Ltd. | Samut Sakhon, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo Medical Equipment (shanghai) Co. Ltd. | Songjiang Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo (Shanghai) Industries Co., Ltd | Songjiang Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laerdal Medical (suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lian Xin Toys Ltd | DongGuan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Aoke Medical Equipment Co.,ltd. | Lianyungang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifelong Meditech Private Limited | Gurugram Haryana, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linhai Deyi Plastic Co., Ltd | Linhai City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luv N' Care, Ltd. | Monroe, LA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mallinckrodt Hospital Products, Inc. | Hazelwood, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mattes Instrumente GMBH | Tuttlingen-Nendingen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medico Industries & Trade Co., Ltd. | SHIJIAZHUANG Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditec Technology Company Limited | Bac Ninh, Vietnam | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Medmolds | karachi Sindh, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medxl Inc | Pointe-Claire Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meed Skills Surgical | SIALKOT Punjab, Pakistan | 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 | |
| Mida Precision Mold Corporation | My Yen Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monitex Industrial Co., Ltd. | SAN-CHUNG CITY Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Munchkin Inc. | Van Nuys, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medbio Orchard Park | Orchard Park, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanning Sixtant Biotechnology Co., Ltd | Nanning Guangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Albert Novosino Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, 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 | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nupur Technologies | Buffalo, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ouachita Contract Manufacturing, LLC | Monroe, LA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promisemed Hangzhou Meditech Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Jayamas Medica Industri Tbk | Sidoarjo Jawa Timur, Indonesia | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsecare Medical, LLC. | Plaistow, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primecare Medical (Suzhou) Co.,Ltd. | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Recibio, Inc. | Richmond, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhinosystems, Inc. | Brooklyn, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ribbel International Ltd. | SONEPAT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Medical GMBH + Co. KG | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Set Medikal Sanayi Ve Ticaret Anonim Sirketi | esenyurt Istanbul, Turkey | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Huihu Medical Appliance Co. Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Wealy Medical Instrument Co., Ltd. | SHANTOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Baria Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mlikang Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Moye Technology Co Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Sze Industrial (shenzhen) Co., Ltd | SHENZHEN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Singgao Precision Technology (dongguan) Co., Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Splash Medical Devices, LLC | Atlanta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPM Medicare Pvt, Ltd. | NOIDA Uttar Pradesh, India | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSN Solutions | Henrico, VA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suministros Y Desechables Skkyd S.A. De C.V. | Naucalpan Estado de Mexico, Mexico | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgin Surgical Instrumentation, Inc. | Scottsdale, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract 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 Pipi Medical Products Co.,ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Xodus Medical Company Limited | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Small Beginnings Inc. | Hesperia, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sol-Millennium Medical, Inc. | Chicago, IL, United States | Complaint file establishment, 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 | |
| Syntech Development & Manufacturing | Chino, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tai-Shiny Technology Co., Ltd. | Guishan District Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tee-Zed Products, LLC | Greensboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tekno Medical Optik-Chirurgie GMBH | TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Metrix Company | Dubuque, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tools For Surgery, LLC | Stony Brook, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Total Titanium, Inc. | Red Bud, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Towne Brothers (pvt.), Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 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 | |
| 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 | |
| Think Green Limited | Kumeu Auckland, New Zealand | 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 | |
| Vastrade Manufacturing Corporation | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Medical Plastic JSC | Tam Diep Ward Ninh Binh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Zuoyou Medical Technoloyg Co.,ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | Weihai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welmed, Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Jieboya Technology Co.ltd | Xiamen Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Longzhiyuan Plastic Co., Ltd | Xiamen City Fujian, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xodus Medical, Inc. | New Kensington, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zain's Medical Image | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zepf Medical Instruments GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Aicor Medical Technology Co., Ltd. | Linhai Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hope Pharma Ltd | Wenzhou Zhejiang, China | Contract manufacturer, 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 LONGDE PHARMACEUTICAL Co., Ltd | HANGZHOU Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Longtime Biological Technology Co., Ltd. | Zhuhai City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeek Medical Devices, LLC | Doral, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 5, 2020. 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.