Skip to the page

Data / Medical devices / Joint, Knee, External Brace

Joint, Knee, External Brace (ITQ): 377 FDA-registered makers in 39 countries

377 establishments in 39 countries are registered with the FDA to make Joint, Knee, External Brace (product code ITQ, Class 1, 21 CFR 890.3475). 1 of them has a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on June 24, 1983, and lists 6 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
ITQ
Device class
1
Regulation
890.3475
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China124
United States95
Taiwan34
Vietnam19
Mexico14
India13
South Korea8
Germany8
Cambodia7
Canada4
Turkey4
Italy4
United Kingdom3
Dominican Republic3
Thailand3
Netherlands2
Pakistan2
Japan2
Hong Kong2
France2
Tunisia2
Guatemala2
Latvia2
Spain2
Australia2
Chile1
Sweden1
Hungary1
Brazil1
Colombia1
Malaysia1
Egypt1
Indonesia1
Iceland1
Austria1
Bulgaria1
Argentina1
Czechia1
Bangladesh1

Makers of Joint, Knee, External Brace

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Exporter to the US1November 12, 1980000api.fda.gov
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
3M Edumex, S.A De C.VCD. JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Acode Sporting Goods Company LimitedHo Chi Minh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Actlife Technology Co., Ltd - Thanh Hoa BranchTrung Chinh Commune Thanh Hoa, VietnamManufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aider Inc.Gangseo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Alpha Medical L.L.C.Rock Hill, SC, United StatesManufacturer0000api.fda.gov
Alps Xiangtan Prosthetic & Orthotic Co., Ltd.Xiangtan, Hunan, ChinaManufacturer0000api.fda.gov
Amc Global (cambodia) Co., LtdPhnom Sruoch District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Amitofo Inc.Denver, CO, United StatesManufacturer0000api.fda.gov
Anatomical Concepts, Inc.Poland, OH, United StatesManufacturer0000api.fda.gov
Anhui Yibao Home Textile Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Huakang Medical Products FactoryHengshui Hebei, ChinaManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Aspen Medical Products, LLCIrvine, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Aupcon Medical Technology (wuxi) Co., Ltd.Wuxi Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Anhui Kangfu Industrial Foreign Trade Co.,LtdTianchang Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Bangni (vietnam) Industrial Company LimitedHo Chi Minh City, VietnamManufacturer0000api.fda.gov
Baoji Shengtaike Industry & Trade Co. Ltd.Baoji City Shanxi, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, NetherlandsComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Beijing Bohaikangyuan Medical Devices Co.,ltd.Beijing Economic and Technological Development Area, ChinaManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Benik Corp.Silverdale, WA, United StatesManufacturer0000api.fda.gov
Bestreat Safety & First Aid Solution Co., LtdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Bionic Power Inc.Vancouver British Columbia, CanadaManufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
BishopShreveport, LA, United StatesManufacturer0000api.fda.gov
BL Tech Co., Ltd.Chuncheon-si Gangwon, South KoreaManufacturer0000api.fda.gov
Blatchford Products LimitedBASINGSTOKE Hampshire, United KingdomManufacturer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
BMS Co., Ltd.Paju Gyeonggi, South KoreaManufacturer0000api.fda.gov
Boston Brace International, IncorporatedStoughton, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Brace Boss, LLCCypress, TX, United StatesSpecification developer0000api.fda.gov
Braceability, Inc.Cedar Falls, IA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bracesox, The OriginalSoquel, CA, United StatesManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (3)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (4)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
BSN Medical GmbHHamburg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bauerfeind USA, INC.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
Blatchford, Inc.Miamisburg, OH, United StatesManufacturer0000api.fda.gov
Bort GmbHWEINSTADT-BENZACH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Camp Scandinavia ABHELSINGBORG Skane, SwedenExporter to the US, Manufacturer0000api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.Gebze Kocaeli, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Capital Sports Corporation (pvt) Ltd.Sialkot Punjab, PakistanComplaint file establishment, Manufacturer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Wenyu Medical Instruments Co., Ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Chrisofix Hungary KFT.Budapest, HungaryManufacturer0000api.fda.gov
CK Sports Co.,ltdKrong Bavet Svay Rieng, CambodiaManufacturer0000api.fda.gov
Comatrix Technology Vietnam Company LimitedHo Chi Minh City, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Comforback IncAuburndale, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Comfort Plus CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Comfy Health Group Co., Ltd.Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Contour Products IncCharlotte, NC, United StatesSpecification developer0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesSpecification developer0000api.fda.gov
CR Uno Industrial Co. LtdTaichung City, Taiwan, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Calze G.T. SrlCASALOLDO Mantova, ItalyManufacturer0000api.fda.gov
Core Products International IncChetek, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Corflex CaribeSanto Domingo Este, Dominican RepublicComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
D-M Chain CooperativeKAHOKU Ishikawa, JapanContract manufacturer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Dawn Breeze Int'l Trading LimitedWan Chai Hong Kong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dela De Mexico S De RL De CVTIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Dela IncorporatedWard Hill, MA, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Direcsource LimitedHong Kong, Hong KongContract manufacturer0000api.fda.gov
Disk DR. Co., Ltd.Hanam-si Gyeonggi, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Djo France SASMOUGUERRE Pyrenees-Atlantiques, FranceExporter to the US, Specification developer0000api.fda.gov
DJO TunisiaSfax, TunisiaManufacturer, Repackager or relabeler0000api.fda.gov
DJO TunisieSfax, TunisiaManufacturer0000api.fda.gov
Djo, LLCVista, CA, United StatesManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Docbrace (cambodia) Co., LtdPhnom Penh Capital, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Dong Guan Yunzhishang Health Technology Co.,ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Ness Sports Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Ruitai Sports Technology Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Vincent Rehab Devices Company LimitedDONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Dongguan Well Sport Co LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Dragon Right Co., LtdTaipei, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dynasplint Systems, Inc.Stevensville, MD, United StatesManufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Park Sport Products Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan SAVA Sporting Products Co.,LtdDongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongguan Sinohome LimitedDongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Tutamen Metalwork Co.,LTD.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesSpecification developer0000api.fda.gov
E.M. Adams Co., Inc.Fort Pierce, FL, United StatesManufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Emperor (VN) Company LimitedBen Lu District Long An, VietnamManufacturer0000api.fda.gov
Ergoactives, LLCMiami, FL, United StatesSpecification developer0000api.fda.gov
Electrostim Medical Services, Inc.Tampa, FL, United StatesSpecification developer0000api.fda.gov
F.G.P. S.R.L.DOSSOBUONO Verona, ItalyContract manufacturer0000api.fda.gov
Fenglin Industry Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Fior And Gentz GMBHLueneburg Lower Saxony, GermanyManufacturer0000api.fda.gov
Firstkind LtdHigh Wycombe Buckinghamshire, United KingdomSpecification developer0000api.fda.gov
Fit For Life, LLCEmpire State, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Foshan Huafukang Medical Technology Co. LtdFoshan City Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Fung Lead Medical & Sports Co., Ltd.Nantou City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Fuzhou Liansheng Sports Equipment Co. LtdFUZHOU, MAWEI DISTRICT Fujian, ChinaManufacturer0000api.fda.gov
Fuzhoushi Cangshanqu Linke MaoyiyouxiangongsiFUZHOU Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaManufacturer0000api.fda.gov
Gemore Technology Co., Ltd.TAN SHUI New Taipei, TaiwanSpecification developer0000api.fda.gov
Ghi Fu Technology Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Golden Aim International LtdShenzhen City,, GUANGDONG, CHINA, Hong KongContract manufacturer0000api.fda.gov
GRD BiomechanicsDeland, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Good Time Health Care Products Co., Ltd.Ho Chi Minh City Binh Duong, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hamaji Industry (thailand) Co., Ltd.Bangkok Krung Thep Maha Nakhon, ThailandContract manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hebei Yinuan Biotechnology Co.,ltd.Shijiazhuang City Hebei, ChinaManufacturer0000api.fda.gov
Hebei Youjie Medical Devices Co., LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei Baoguo Information Technology Co., LtdHefei Anhui, ChinaSpecification developer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Runde Medical Instruments Co.,ltdHengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Tianjian Medical Supplies Co., Ltd.ShenZhou City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hengshui Xukang Medical Appliances Co., Ltd.Hengshui City Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Heptex Industry Company LimitedViet Tri Phu Tho, VietnamExporter to the US, Manufacturer0000api.fda.gov
Hidrolight Do Brasil SAGAROPABA Santa Catarina, BrazilManufacturer0000api.fda.gov
Hing Ka Yuen Health Technology (changzhou )co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Huae Trade Technology Co.,ltd.Beijing, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Huiling (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Hely & WeberDfw, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Hubei Dacheng Medical Technology Co., LTD.XianNing City Hubei, ChinaContract manufacturer0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Icarus Medical LLCCharlottesville, VA, United StatesManufacturer0000api.fda.gov
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Incrediwear Holdings, Inc.Chico, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Indaco S.R.L.Filiano Potenza, ItalyManufacturer0000api.fda.gov
IPE Plastic & Hardware Industy, LTDDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Irufa Industrial Group Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Jandty Health Inc.Taichung, TaiwanRepackager or relabeler, Specification developer0000api.fda.gov
Jiangsu Reak Healthy Articles Co.,ltdYangzhong City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Xiangyu Fitness Equipment Co., Ltd.Yangzhong Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yulong Medical Technology Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Jiangxi Handasen Industry Co., LtdShangrao Jiangxi, ChinaManufacturer0000api.fda.gov
Jiangxi Junhong Sporting Goods Co., Ltd.Ta Khmau Kandal, CambodiaExporter to the US, Manufacturer0000api.fda.gov
Jiangyin Unixcare Medical Devices Co.,ltdJiangyin Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jianxing Shoe Co. Ltd.Foshan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jinhua Beili Knitting Co.,ltd.JINHUA Zhejiang, ChinaManufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
JKH Health Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Juneng Sports Goods Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kamex International S.A.SCajica Cundinamarca, ColombiaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Kanapo Prosthetics And Orthotics Ltd.Kitchener Ontario, CanadaManufacturer0000api.fda.gov
Kang Wen Sports Products(cambodia)co.,ltd.Treang District Takeo, CambodiaManufacturer0000api.fda.gov
Kao Chen Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Kinetec UsaJackson, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Koleno Global Ortho Innovation LLPJAIPUR Rajasthan, IndiaManufacturer0000api.fda.gov
Koolcare Medical Equipment (vietnam) Company LimitedHo Chi Minh City, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Koolcare Technology Co., LtdXuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim SirketiSalihli Manisa, TurkeyManufacturer0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesSpecification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Le Shin International Co., Ltd.Kaohsiung,, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Life Wear Technologies, Inc.Pompano Beach, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Lifewear Technologies India Private LimitedSolan Himachal Pradesh, IndiaManufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lsez Sia Lauma Medical / Lauma Medical Lsez LLCLiepaja, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Lu Lu Sports Corp.Nantou City, TaiwanContract manufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Lunarsea Personal Care Supplies SDN. BHDPUNCAK ALAM Selangor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
M2 Global Co., Ltd.Ho Chi Minh City Binh Duong, VietnamExporter to the US, Manufacturer0000api.fda.gov
Magway Trading Inc.Markham Ontario, CanadaForeign private label distributor, Specification developer0000api.fda.gov
Mammon International Corp.Dongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Mammon International Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Manamed LLCDenton, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MD OrthopaedicsWayland, IA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
Medi Se And Co. KGBAYREUTH Bavaria, GermanyManufacturer, Specification developer0000api.fda.gov
Medi-Dyne Healthcare Products, Inc.Colleyville, TX, United StatesSpecification developer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
MFG AmpTijuana Baja California, MexicoManufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Mobility Braces, LLCNorth Salt Lake, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mobius TechnologiesKetchum, ID, United StatesSpecification developer0000api.fda.gov
Moosni Internacional SA De CVHERMOSILLO Sonora, MexicoManufacturer0000api.fda.gov
More Medical Global Co., LtdTaichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
MS CorporationGimpo Gyeonggi, South KoreaManufacturer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0010api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Myhung Garment And Trading Joint Stock CompanyMy Hao Dist Hung Yen, VietnamContract manufacturer0000api.fda.gov
Motive Health, Inc.Tempe, AZ, United StatesManufacturer0000api.fda.gov
Nanjing 3H Medical Products Co.,ltd.NANJING Jiangsu, ChinaContract manufacturer, Exporter to the US, Repackager or relabeler0000api.fda.gov
Nanjing Asn Medical Technology Co.,ltdNANJING Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nantong Haochuan Industry Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Nea International BVMAASTRICHT-AIRPORT Limburg, NetherlandsManufacturer0000api.fda.gov
Neo G LimitedKnaresborough North Yorkshire, United KingdomManufacturer0000api.fda.gov
Ningbo Just Soon Industrial LimitedNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Landing Technology Company Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Skyey Industry & Trade Co.ltdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nippon Sigmax Co., Ltd.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Ningbo Chendong Sports & Sanitarian Co.,ltdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nureca Technologies Private LimitedMohali Punjab, IndiaManufacturer0000api.fda.gov
Onsurgical Corp.Seoul, South KoreaManufacturer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, IncSan Pedro De Macoris, Dominican RepublicManufacturer, Repackager or relabeler0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
ORTEC Co., LTD.Busan, South KoreaManufacturer0000api.fda.gov
Orthocor Medical Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Overland Int'l CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Osskin Ortho Inc.Montreal Quebec, CanadaManufacturer0000api.fda.gov
Ossur Iceland ehf.Reykjavik, IcelandComplaint file establishment, Specification developer0010api.fda.gov
Ossur MexicoTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Otto Bock Healthcare Products GmbHVienna Wien, AustriaManufacturer0000api.fda.gov
Ottobock Manufacturing Bulgaria EOODBlagoevgrad, BulgariaContract manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyExporter to the US, Manufacturer, Specification developer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Paifu Comfort Industrial Co LtdTainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Pantymed S.A.BUENOS AIRES Buenos Aires, Ciudad Autonoma de, ArgentinaManufacturer0000api.fda.gov
Pavis S.P.A.Buguggiate Varese, ItalyManufacturer0000api.fda.gov
Pintoli Enterprises Co., Ltd.Changhua County, TaiwanManufacturer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
POD Active Pty LtdGeelong Victoria, AustraliaSpecification developer0000api.fda.gov
Power Well Healthcare Technology Co., Ltd.Changhua County, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Prim,s.a.Mostoles Madrid(Province), SpainManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Praegear Viet Nam Co., Ltd.Duc Hoa District Long An, VietnamContract manufacturer0000api.fda.gov
Precision Medical ProductsRocklin, CA, United StatesSpecification developer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
R&R Medical Corporation Ltd.Sanchong District New Taipei, TaiwanManufacturer0000api.fda.gov
Reak Vietnam Company LimitedNhon Trach Commune Dong Nai, VietnamExporter to the US, Manufacturer0000api.fda.gov
Refirmance Athletic Protector Co., Ltd.Taichung, TaiwanManufacturer0000api.fda.gov
Relief MedicalPhoenix, AZ, United StatesSpecification developer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Rich Joy Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Rival Vietnam Co.,ltdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Ryder Pet Supplies (cambodia)co., LtdSihanouk Preah Sihanouk, CambodiaManufacturer0000api.fda.gov
Reflex GroupOceanside, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Secure Manufacturing (thailand) Co., Ltd.Bangkok Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Sheico Thailand Co., Ltd.Marbyangporn Pluakdang Rayong, ThailandExporter to the US, Manufacturer0000api.fda.gov
Shenzhen City U-Lucky Sporting Goods Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Shenzhen Tohachi Industrial Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Weprotex Technology Product Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Xinzhengyu Technology Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Sia Tonus Elast / Tonus Elast LLC.Grinvalti,Nicas pag Nicas Novads, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Sigmax(huzhou)medical.co.,ltd.Huzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Simple Medical (shenzhen) LimitedShenzhen Guangdong, ChinaSpecification developer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Special Protectors Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
SPORLASTIC GMBH & Co.KGNURTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
ST&G Usa Corporation / ChoiBrea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
STREIFENEDER ortho.production gmbHEMMERING Bavaria, GermanyExporter to the US, Manufacturer0000api.fda.gov
Suzhou Sunmed Co., LtdSUZHOU CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Honca Import and Export co.,LtdShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Simple Manufacturing DG LtdDongguan City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Sinomax (Vietnam) Household Products LimitedBAC TAN UYEN Binh Duong, VietnamManufacturer0000api.fda.gov
Sun Polar International Co., Ltd.Changhua County, TaiwanManufacturer0000api.fda.gov
Symbiont Logistics, LLCPhoenix, AZ, United StatesManufacturer0000api.fda.gov
Ta Lai Sporting Goods Enterprises Co. Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Taicang Yigao Medical Technology Co.,ltdTaicang Jiangsu, ChinaManufacturer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
Thuasne Deutschland GMBHBurgwedel Lower Saxony, GermanyManufacturer0000api.fda.gov
Thuasne SASSAINT ETIENNE Hauts-de-Seine, FranceExporter to the US, Manufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Top Longmax Products Co., Ltd.Taichung, TaiwanContract manufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Trulife, Inc.Bellingham, WA, United StatesManufacturer0000api.fda.gov
Tutamen De Mexico, LLCTijuana Baja California, MexicoManufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaContract manufacturer, Manufacturer0000api.fda.gov
TZY Shenq Enterprise, Co., LtdTaichung, TaiwanContract manufacturer0000api.fda.gov
Tenacious Holdings IncSaint Paul, MN, United StatesSpecification developer0000api.fda.gov
Think Big Industrial Company LimitedPudong Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Thuasne Czech Republic S.R.OPREDKLASTERI Brno-Venkov, CzechiaContract manufacturer0000api.fda.gov
Thuasne, LLCManchester, NH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0010api.fda.gov
Unite Medical, LLCLithia Springs, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
United Pacific Industries Pty. Ltd.KILSYTH Victoria, AustraliaContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
United Surgical LLCLaotto, IN, United StatesManufacturer, Repackager or relabeler, Specification developer0010api.fda.gov
United Surgical, Ltd.P.U. Kadda, Gazipur, BangladeshContract manufacturer, Manufacturer0000api.fda.gov
Vietnam Yetitech Equipment Company LimitedN/A Hung Yen, VietnamExporter to the US, Manufacturer0000api.fda.gov
Viotin Trading Limited, S.A. De C.V.Mexico City Ciudad de Mexico, MexicoManufacturer0000api.fda.gov
VIVE Health LLCNaples, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd StiKUCUKCEKMECE Istanbul, TurkeyContract manufacturer, Manufacturer0000api.fda.gov
VTS ONE MEMBER CO., Ltd.Hai Phong City, VietnamExporter to the US, Manufacturer0000api.fda.gov
Variteks Ortopedi Sanayi A.S.Catalca Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Vonco Products, LLCFortville, IN, United StatesContract manufacturer0000api.fda.gov
Weihai Dishang Medical Technology Co.,ltdWeihai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Welkong Sports Industrial Co.,ltdDongguan city Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wellpower Sporting Goods Co., Ltd.Dong Guan Guangdong, ChinaContract manufacturer0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Winning Industrial Co., Ltd.DONGGUAN Guangdong, ChinaContract manufacturer, Foreign private label distributor0000api.fda.gov
WP Sports (cambodia) Co., Ltd.Bavet City Svay Rieng, CambodiaContract manufacturer0000api.fda.gov
Wuxi Wemade Healthcare Products Co., Ltd.Wuxi Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wealthy Plastic & Electronic Products Company LimitedHuizhou City Guangdong, ChinaContract manufacturer0000api.fda.gov
Wealthy Plastic & Electronic Products Company LimitedHuizhou City Guangdong, ChinaContract manufacturer0000api.fda.gov
Xiamen Bosegrow Medical Equipment Co.,ltdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen Chengli Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Deland Medical Equipment Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Huakang Orthopedic Co.,ltdXiamen City Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Longstar Medical Equipment Co.,ltdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaContract manufacturer0000api.fda.gov
Xiamen Twe Orthopedics Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xo Armor Technologies IncAuburn, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Xtreme Orthopedics, LLC D/B/A FlexxlineFayetteville, AR, United StatesSpecification developer0000api.fda.gov
Xiamen Benli Medical Technology Co., Ltd.Xiamen City Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Aolikes Sports Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Feiyali Sporting Goods Co.ltdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangzhou Haiwang Toothbrush FactoryYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangzhou Jindu Sporting Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Juli Sports Articles Co.,ltd.YangZhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Qiangjing Sports Products Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Qionghua Sports Goods Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Sensport Healthcare Supplies Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Zhilin Sports Items Co., LtdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yiwu Inwell Craft&gift Co.,ltdJin Hua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yunbiotech Co.,ltd.Namdong-gu Incheon, South KoreaManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang KMJK Medical Device Co.,ltdHUZHOU CITY Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Todo Hardware Manufacture Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zodiacal Overseas Private LimitedJODHPUR Rajasthan, IndiaManufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Cathaya Health Care Devices Co., Ltd.Huzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Steriger Sports Medicine Technology Co.,LtdYiwu Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
pfs med, incSpringfield, OR, United StatesManufacturer, Remanufacturer0000api.fda.gov

Updated June 24, 1983. 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.