Data / Medical devices / Catheter And Tip, Suction
Catheter And Tip, Suction (JOL): 216 FDA-registered makers in 21 countries
216 establishments in 21 countries are registered with the FDA to make Catheter And Tip, Suction (product code JOL, Class 2, 21 CFR 880.6740). 11 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 84 510(k) clearances under this code, the latest on August 12, 2005, and lists 15 recall events (2 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
- JOL
- Device class
- 2
- Regulation
- 880.6740
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 74 |
| China | 55 |
| Germany | 26 |
| Mexico | 16 |
| Pakistan | 8 |
| United Kingdom | 6 |
| Taiwan | 5 |
| India | 4 |
| Malaysia | 4 |
| Switzerland | 3 |
| Japan | 2 |
| South Korea | 2 |
| Canada | 2 |
| Indonesia | 2 |
| Belarus | 1 |
| Singapore | 1 |
| Italy | 1 |
| Thailand | 1 |
| Turkey | 1 |
| Costa Rica | 1 |
| Lithuania | 1 |
Makers of Catheter And Tip, Suction
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 |
|---|---|---|---|---|---|---|---|---|
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 4 | January 19, 1989 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 3 | January 19, 1989 | 0 | 1 | 0 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 2 | January 19, 1989 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 2 | January 19, 1989 | 0 | 0 | 0 | api.fda.gov |
| PMT Corp. | Chanhassen, MN, United States | Manufacturer, Specification developer | 2 | May 30, 1980 | 0 | 0 | 0 | api.fda.gov |
| Axiom Medical, Inc. | Torrance, CA, United States | Manufacturer | 1 | July 29, 1977 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 1 | February 1, 1994 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | September 29, 1983 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | September 29, 1983 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | September 29, 1983 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | May 11, 1994 | 0 | 0 | 0 | api.fda.gov |
| Addn Solutions GMBH & Co. KG | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alleva Medical Devices | Pomona, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angiplast Pvt. Ltd. | Kheda Gujarat, India | 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 | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Medsource Group Limited | Hongkong, China | Contract manufacturer, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asomedica Co. Ltd | Smolevichi District Minsk, Belarus | Manufacturer | 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 | |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Battech | Irvine, CA, United States | Manufacturer, Repackager or relabeler, Reprocessor | 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 | |
| Blache Medical GMBH & Co. KG | Wellendingen Baden-Wurttemberg, Germany | Contract 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 | |
| Bonree Medical Co., Ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bothwin Medical Technology (SG) Pte. Ltd. | Singapore Central Singapore, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BR Surgical LLC | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 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 | |
| BihlerMed, LLC | Phillipsburg, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Charmant, Inc. | Sabae-City, Fukui-Pref., Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chinamed Products (china) Ltd. | Gaoyao District Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent GMBH & Co. KG | LANGENAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Medical LLC | Bloomington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Morristown, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Batavia, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curaco Inc | Seongnam-si Gyeonggi, South Korea | 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 (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou CareU Medical Instruments Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cixi Qimei Combination Tool Packing Factory | Cixi City Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTR Medical Ltd | Swansea, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dufner Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EFINGER INSTRUMENTS GmbH & Co. KG | SPAICHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elmed Instruments (pvt). Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endo Tech Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euronda SPA | Sandrigo Vicenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evonos GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | 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 | |
| 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 | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Ecan 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 | |
| Guenter Bissinger Medizintechnik GMBH | TENINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holger Bumueller LLC | Rutherfordton, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Manufacturing Services Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huana Technology (thailand) Co., Ltd. | Bang Pakong Chachoengsao, Thailand | Exporter to the US, 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 Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, 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 | |
| Heager GmbH | HAAN North Rhine-Westphalia, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | 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 | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ilg Medizintechnik GMBH | DURCHHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Plasticas Medicas, S.A. De C.V. | Ayala Morelos, Mexico | 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 | |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Specification developer | 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 | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hanheng Medical Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rongye Technology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JR Montagearbeiten | TUTTLINGEN Baden-Wurttemberg, Germany | Contract 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 | |
| Karl Klappenecker GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 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 | |
| L-D Tool & Die Division Of Madix Engineering | Ottawa Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios PISA S.A. de C.V. | GUADALAJARA Jalisco, Mexico | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 4 | 1 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 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 | Chester, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millennium Surgical Corp | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MIZUHO Corporation Gosen Factory | Gosen Niigata, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moser-Baer AG | Sumiswald Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanning Tecbod Biological Technology Co.,ltd | Nanning Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo Zhejiang, China | Contract manufacturer, 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 Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nouvag AG | GOLDACH Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OBP Medical Corporation | Lawrence, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Obp Surgical Corporation | Lawrence, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oertel Medical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oralkleen LLC | Phoenix, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopedic Sciences, Inc | Overland Park, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Patient Shield Concepts LLC | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peter Lazic GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plastics Plus Technology, Inc. | Redlands, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Platform Innovations Inc. | Brighton, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Mexicanos De Resinas SA De CV | ESCOBEDO Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prospect Life Sciences | Westminster, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Vitanova Medical Indonesia | Kec. Cikarang Pusat, Kab. Bekasi Jawa Barat, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Jayamas Medica Industri Tbk | Sidoarjo Jawa Timur, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Hospital Supply Co., Ltd | Tongluo Township Miaoli, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primecare Medical (Huzhou) Co.,Ltd. | Hu zhou Zhejiang, China | Contract 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 | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Romsons International | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabin Corporation | Blmgtn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sage Products LLC | Cary, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sewoon Medical Co., Ltd. | Cheonan-si Chungnam, South Korea | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Ruyue Medical Technology Co.,ltd. | Binzhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffmed Limited | Rotherham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Yuanding Medical Device Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Costa Rica Division S.R.L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMD Manufacturing LLC | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgimark, Inc. | Yakima, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surtex Instruments Ltd | London Surrey, United Kingdom | Manufacturer | 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 | |
| Swiftsure Innovations Inc. | Pasadena Newfoundland and Labrador, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Xodus Medical Company Limited | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T.A. Walthem & Company | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Temrex Corp. | Freeport, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianck Medical Co.,ltd | Huizhou Guangdong, China | 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 | |
| TKR Huanan Electronics (dongguan) Co., Ltd. | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract 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 | |
| Trinity Sterile, Inc. | Salisbury, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teufel & Gerlach GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | 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 | |
| Volgo Care International (private) Limited | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | WENZHOU Zhejiang, China | Contract 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 | |
| WILDmedical GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract 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 | |
| Westmed de Mexico, S.A de C.V | MAGDALENA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xodus Medical, Inc. | New Kensington, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yadu Medical (henan) Co., Ltd | Changyuan Henan, China | Manufacturer, Specification developer | 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 Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Sungood Technology Co.,ltd | Hangzhou Zhejiang, China | Exporter to the US, 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 | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| e.l. zepf GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 12, 2005. 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.