Data / Medical devices / Splint, Extremity, Non-Inflatable, External, Non-Sterile
Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC): 131 FDA-registered makers in 22 countries
131 establishments in 22 countries are registered with the FDA to make Splint, Extremity, Non-Inflatable, External, Non-Sterile (product code NOC, Class 1, 21 CFR 878.3910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (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
- NOC
- Device class
- 1
- Regulation
- 878.3910
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 53 |
| United States | 38 |
| Taiwan | 6 |
| South Korea | 6 |
| Mexico | 3 |
| United Kingdom | 3 |
| India | 3 |
| Cambodia | 2 |
| Germany | 2 |
| Canada | 2 |
| Turkey | 2 |
| Sweden | 1 |
| Slovakia | 1 |
| Vietnam | 1 |
| Israel | 1 |
| Brazil | 1 |
| Malaysia | 1 |
| Egypt | 1 |
| Finland | 1 |
| Iceland | 1 |
| Thailand | 1 |
| Italy | 1 |
Makers of Splint, Extremity, Non-Inflatable, External, Non-Sterile
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 |
|---|---|---|---|---|---|---|---|---|
| A & I Industries Ltd | FOSHAN CITY Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AB Germa,sweden | KRISTIANSTAD Skane, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aero Healthcare | Valley Cottage, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphapointe | Kansas City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amc Global (cambodia) Co., Ltd | Phnom Sruoch District Kampong Speu, Cambodia | Contract 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 | |
| Anping Guardian Medical Equipment Co.,ltd | Hengshui Hebei, China | Exporter to the US, Manufacturer | 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 | |
| ActivArmor | Port Saint Lucie, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airflo (Xiamen) Medical Co., Ltd. | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BECON MEDICAL Ltd. | Batavia, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Health Medical Technology Co., Ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blessing Cathay Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN Medical GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN Medical S.A. de C.V. | Reynosa Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cambridge Ortopaedic Labs Ltd | Market Harborough Leicester, United Kingdom | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carolina Narrow Fabric Co. | Winston-Salem, NC, United States | Specification developer | 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 | |
| Comebetter (guangzhou) Technology Co., Ltd | Guangzhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Plus Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Darco International, Inc. | Huntington, WV, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dick Medical Supply | Columbus, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIMENSION ORTHO Inc. | Philadelphia, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer, 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 Supercare Medical Products Co., Ltd | Dongguan Guangdong, China | Exporter to the US, 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 | |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Park Sport Products Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Vigor Textile Co.,Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emsrun Group | Wuxi Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EarGear LLC | Eden Prairie, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emergency Products & Research, Inc. | Kent, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essentia Industries Ltd. | Dong Guan Guangdong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faretec, Inc. | Painesville, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno Canada, Inc. | Oakville Ontario, Canada | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno-Washington, Inc. | Wilmington, OH, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno Slovakia s.r.o. | Slovak Republic Trenciansky, Slovakia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G Surgiwear Limited | Shahjahanpur Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garware Healthcare India Pvt Ltd | Satara Maharashtra, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauke (hubei) Healthcare Co., Ltd | Huanggang City Hubei, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gero3d Ltd | Tel Aviv-Yafo Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Meicen Medical Equipment Co., Ltd. | foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou New Design Biotechnology 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 USA Inc. (previously AVCOR Health Care Products, Inc.) | Fort Worth, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Headstar Medical Products Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Nuri Co., Ltd. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heitco, Inc. | Avon, OH, United States | Contract 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 Tianjian Medical Supplies Co., Ltd. | ShenZhou City Hebei, China | Contract manufacturer, Exporter to the US, 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 | |
| Hidrolight Do Brasil SA | GAROPABA Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Ming Enterprise Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar 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 | |
| Hubei Dacheng Medical Technology Co., LTD. | XianNing City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I.V. House | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invictus Global Limited | SWADLINCOTE Derbyshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Saikang Medical Equipment Co., Ltd | Zhangjiagang Jiangsu, China | Contract manufacturer, 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 | |
| Jiangsu Yangtze River Medical Technology Corp. | Taizhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd | Zhangjiagang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Join Enterprise, Ltd. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kang Wen Sports Products(cambodia)co.,ltd. | Treang District Takeo, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kentec Medical, LLC | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LKL Advance Metaltech Sdn Bhd | Seri Kembangan Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsource Factory,inc. | CHANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| McARTHUR MEDICAL SALES, INC. | Rockton, Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo, Zhejiang, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORTEC Co., LTD. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OY Primo Finland AB | Vaasa Pohjanmaa, Finland | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Iceland ehf. | Reykjavik, Iceland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puli Healthcare (thailand) Co., Ltd. | Bangkok Samut Prakan, Thailand | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Posey, S. de R.L. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RED MEDICAL CORPORATION dba Med Tech Sweden Inc (Unit # 4, 3 and Office) | Geneseo, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Redicare LLC | Congers, NY, United States | Repackager or relabeler, Specification developer | 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sam Medical Products | Tualatin, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Yabin Medical Technology Co., Ltd | Zibo Shandong, China | Manufacturer | 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 No. 2 Medical College Duhang Medical Equipment Factory | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang Liaoning, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Weprotex Technology Product Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Runyi Medical Device Technology Co.,ltd. | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spencer Italia SRL | Sala Baganza Parma, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stroke Holder Inc. | Las Vegas, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmedica | Redding, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Sunmed Co., Ltd | SUZHOU CITY Jiangsu, 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 | |
| Shijiazhuang Aofeite Medical Device Co.,Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Yide Medical Device Manufacturing Co., Ltd. | Shijiazhuang City Hebei, China | Contract manufacturer, Exporter to the US, 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 | |
| Taizhou Xinkang Medical Materials Co., Ltd | Taizhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Talexmedical, LLC | Malvern, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hygenic Company, LLC | Akron, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Medi-Kid Co., Inc. | Hemet, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomocross International Co., Ltd | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Shelf Manufacturing, LLC | Tracy, CA, United States | Manufacturer | 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 | |
| Tender Corporation | Littleton, NH, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomato M&C Co.,Ltd | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd Sti | KUCUKCEKMECE Istanbul, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variteks Ortopedi Sanayi A.S. | Catalca Istanbul, Turkey | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Woosam Medical Co., Ltd. | Paju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-CEN-TEK GmbH & Co. KG | Wardenburg Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Ortocare Sports Health Co.,ltd. | Xiamen Free Trade Zone Fujian, China | 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 | |
| Yoorim Corp. | EUMSEONG-GUN Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Recaring Medical Instrument Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan A&e Machinery Industry Co., Ltd | Zhongshan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan A&j Medical Equipment Co., Ltd. | Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.