Miscellaneous devices · 21 CFR 872 Subpart G
Roll Cotton
FDA device type “Cotton, Roll”.
- Companies listing it
- 191119 makers
- Brands and models
- 253
- 510(k) clearances
- 140 in five years
- FDA name
- Cotton, Roll
510(k) clearances per year, 1976–2026
Companies that list EFN
191 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| American Orthodontics | United States | Maker | Cotton Roll Holders | 44 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier Retraction Caps | 28 | 2026 |
| New Stetic, SA | Colombia | Maker | — | 5 | 2026 |
| Philips Medical Systems International BV | Netherlands | Maker | Cotton Roll · Gauze | 16 | 2010 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Padgett | 2 | 2014 |
| COLTENE Holding AG | Switzerland | Maker | Luna Gold · REOKO Comprecap · ROEKO Comprecap (anatomic) · ROEKO Cotton Pellets · +8 | 1 | 2003 |
| Bioseal | United States | Maker | Dental Roll | 1 | 1988 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | COTTON BALLS · COTTON PADS · Cotton Rolls | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | cotton ball · cotton roll | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Cotton Applicator Tips · Cotton Ball · Cotton Pallet · Cotton Roll | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Cotton Roll | — | — |
| Beyes Dental Inc | Canada | Maker | Cotton Rolls | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Cotton Rolls | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | COTTON, ROLL | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | DENTAL COTTON ROLL | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Cotton Rolls | — | — |
| BH Medical Products Co., Ltd | China | Maker | cotton rolls | — | — |
| NuCare LLC | United States | Maker | Dental Rolls · Saliva Absorption Pads | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | COTTON BALL | — | — |
| AMD Medicom Inc | Canada | Maker | Hedy Cotton Dental Rolls · Medicom Cotton Roll | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Cotton Roll | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Cotton rolls | — | — |
| Medline Industries, LP | United States | Maker | Medline | — | — |
| Produits Dentaires SA | Switzerland | Maker | Cotton Pellets · Cotton Pellets Dispenser | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Dental cotton roll , Dental cotton ball | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Cotton roll | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Cotton, Roll | — | — |
| Boen Healthcare Co Ltd | China | Maker | Absorbent Cotton Roll; Cotton Ball; Cotton Pad; Zig-Zag Cotton Wool · Cotton Roll; Dental Cotton Roll; Absorbent Cotton Wool; Absorbent Cotton Balls | — | — |
| Huzhou Junda Industry Co., Ltd. | China | Maker | Absorbent Cotton Roll · Cotton Ball · Cotton Pad · Zig-Zag Cotton Wool | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Cotton Roll | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | cotton rolls | — | — |
| G.S.T. Corporation Limited | India | Maker | Gold Cross · GSTC · Heuer | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Cotton roll, Dental cotton roll | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Cotton Rolls, cotton roll dispenser | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Cotton rolls | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll | — | — |
| Dukal Corporation | United States | Maker | Dukal Cotton Roll | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | cotton rolls | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Cotton Roll, Cotton Gauze, Dental Dib, Face Protetive Paper | — | — |
| Jujiang Huada Medical Dressing Co., Ltd. | China | Maker | COTTON BALL · COTTON ROLL · cotton roll dispenser · COTTON WOOL · +1 | — | — |
| ASA Dental | Italy | Maker | Cotton Roll | — | — |
| Shanghai D-One International Co., Ltd. | China | Maker | Cotton balls | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | Cotton Roll | — | — |
| Miracle Medical Industries | Egypt | Maker | Asten · ASTN · COTTOMED · DawaAid · +7 | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | Cotton roll | — | — |
| Anhui Ares Medical Technology Co.,Ltd. | China | Maker | dental roll | — | — |
| Changzhou Shengkang Medical Instrument Co.,LTD | China | Maker | Disposable dental cotton rolls | — | — |
| Anhui MedPurest Medical Technology Co Ltd | China | Maker | Medical cotton balls | — | — |
| DeRoyal Industries Inc | United States | Maker | Cotton, Roll - DeRoyal | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | COTTON ROLL | — | — |
| Zhejiang Lidesen Medical Instrument Co., Ltd | China | Maker | Absorbent cotton pad -NCP , non-woven cotton pad,no-sterile and sterile · Absorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball | — | — |
| Anqing Kangmingna Packaging Co.,Ltd | China | Maker | Medical cotton balls | — | — |
| Beijing ZKSK Technology Co., Ltd. | China | Maker | Absorbent Cotton, Absorbent Cotton Ball, Medical Cotton Swabs | — | — |
| Hangzhou Rollmed Co.,Ltd. | China | Maker | ROLLMED | — | — |
| Hubei Lanbin Medical Group Co., Ltd. | China | Maker | Sterile cotton balls | — | — |
| Danameco Medical Joint Stock Corporation | Vietnam | Maker | Cotton ball · D-Care · Medical cotton | — | — |
| Fomed Industries Inc. | China | Maker | Cotton roll | — | — |
| Weihai Xingtai Packaging Products Co., Ltd. | China | Maker | Dental cotton roll | — | — |
| Anji SPENQ Industrial Co., Ltd. | China | Maker | Absorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball | — | — |
| Bong Bach Tuyet Joint Stock Company | Vietnam | Maker | Make-up Remover Pad · Medical cotton · Skin cleansing cotton · Skin Cleansing Dry Cotton Wipes | — | — |
| Gauke (Hubei) Healthcare Co., Ltd | China | Maker | Cotton · Cotton ball · Cotton roll · Zig-zag cotton roll | — | — |
| Larident SRL | Italy | Maker | Cotton Roll Holder | — | — |
| Medipack Medical Packaging Mfg Co | China | Maker | — | — | — |
| Shanghai Joy Crown Industry Co., Ltd | China | Maker | JOY135 | — | — |
| Taizhou Rich Medical Products Co Ltd | China | Maker | Absorbent cotton wool, Absorbent cotton balls · Cotton roll | — | — |
| Wuhan Jacky Jenny Industries Co., Ltd. | China | Maker | Cotton Balls · Cotton Rolls · Cotton With Gauze · Zigzag Cotton | — | — |
| Yiwu Hemai Daily Necessities Co., Ltd. | China | Maker | Isshah, Cotton Swab-Applicator, Absorbent Tipped, Non-Sterile-Bamboo Cotton Swabs Household Use | — | — |
| Yiwu Jiekang Medical Articles Co., Ltd. | China | Maker | Cotton Rolls | — | — |
| Zhejiang kangmin medical&healthcare manufacturing Co.,Ltd | China | Maker | cotton pads,dental cotton roll,pleat cotton,cotton roll | — | — |
| Anji Hongde Medical Products Co Ltd | China | Maker | Cotton Rolls · Dental Cotton rolls · Zigzag Cotton | — | — |
| Yancheng Trancom First Aid Supplies Industrial Co., Ltd | China | Maker | Gauze roll | — | — |
| Allmed Medical Products Co Ltd | China | Maker | Cotton filled Exodontia sponges | — | — |
| Anqing Jiaxin Medical Technology Co., Ltd. | China | Maker | Medical Cotton Ball | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Changzhou Shengjie Medical Product Co., Ltd | China | Maker | — | — | — |
| Dalian Wenjing Wooden Industry Co., Ltd. | China | Maker | COTTON, ROLL | — | — |
| DEGASA S.A. de C.V. | Mexico | Maker | PROTEC COTTON BALLS · PROTEC COTTON, ROLL | — | — |
| Dongguan City Ruimi Gift Products Co Ltd | China | Maker | Cotton; Cotton ball; Cotton roll; Zig-zag cotton roll | — | — |
| Hynaut Health Technology Co., LTD. | China | Maker | cotton, roll | — | — |
| Nantong Jianan Medical Products Co.,Ltd | China | Maker | Absorbent Cotton · Cotton Roll | — | — |
| Ningbo Guangbo medical Technology co.,ltd | China | Maker | Cotton Stick, Cotton Stick | — | — |
| Taizhou Xinkang Medical Materials Co., Ltd | China | Maker | Cotton roll | — | — |
| Wenzhou Scico Medical Corporation Co.,Ltd. | China | Maker | Cotton Roll · Cotton Swabs | — | — |
| 美舒博股份有限公司Medsorb Dominicana, S.A. | Dominican Republic | Maker | DALE MEDICAL PRODUCTS · Omnia | — | — |
| Across Medical Disposables Co., Ltd. | China | Maker | Cotton Roll | — | — |
| Action Packaging | United States | Maker | PROTEC COTTON BALL | — | — |
| AN Lanh Investment and Trading Company Limited | Vietnam | Maker | Alcohol soaked cotton, Zigzag cotton, Makeup remover cotton, Waterproof cotton (other names: Grease cotton) | — | — |
| Anqing Jinghuang Personal Care Products Co., Ltd. | China | Maker | Cotton roll | — | — |
| Apollo Medical Products Corp. | United States | Maker | — | — | — |
| Carwild Corporation | United States | Maker | Omnia | — | — |
| E-Way Viet Nam Company Limited | Vietnam | Maker | Dry cotton tissue/wipes | — | — |
| GD Group USA Company | United States | Maker | COTTON, ROLL | — | — |
| GLX Medical Devices Company Limited | Vietnam | Maker | Cotton Ball | — | — |
| GuangDong Comfort Medical Products Co., Ltd. | China | Maker | COTTON ROLL | — | — |
| Hangzhou Weize Imp & Exp Co., Ltd. | China | Maker | Gauze pad, Gauze roll, Cotton roll | — | — |
| Jiangsu Guangda Medical Material Group Co., Ltd. | China | Maker | Cotton Ball; Cotton Roll | — | — |
| Jieyang Top-Tip'S Daily Use Products Co.,ltd. | China | Maker | COTTON, ROLL | — | — |
| Medwell Medical Products Co., Ltd. | China | Maker | MEDWELL MEDICAL PRODUCTS CO.,LTD | — | — |
| Nantong Hope Industry & Trade Co., Ltd. | China | Maker | COTTON BALL | — | — |
| Ningbo Betterlife Limited | China | Maker | Cotton Ball | — | — |
| Parkom LLC | United States | Maker | Parkom Dental Roll | — | — |
| Planet (Anhui) Medical Products Co., Ltd | China | Maker | COTTON ROLL | — | — |
| Questalpha | Germany | Maker | Sugi | — | — |
| Taizhou Xinjun International Trade Co., Ltd | China | Maker | COTTON ROLL | — | — |
| TNT Moborg Intl. Ltd. | United States | Maker | immobile b | — | — |
| United Health Products | United States | Maker | Hemostyp | — | — |
| Winner Medical Co Ltd | China | Maker | Cotton Roll, Cotton Ball | — | — |
| Wuhan Zonsen Medical Products Co., Ltd | China | Maker | Cotton roll, Dental cotton | — | — |
| Yiwu Ori-Power Medtech Co.,Ltd. | China | Maker | Cotton Swabs | — | — |
| Zhejiang E-WAY Healthcare Co., Ltd. | China | Maker | Dry cotton tissue/wipes | — | — |
| Dongyang City Yonoel Outdoor Products Co.,Ltd | China | Maker | — | — | — |
| Frogfish International Corp. | Taiwan | Maker | — | — | — |
| Jiangsu Likang Medical Products Co., Ltd. | China | Maker | — | — | — |
| Sion Biotext Medical Ltd | Israel | Maker | — | — | — |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Mexico | Maker | — | — | — |
| TIDI Products LLC | United States | Maker | — | — | — |
| Yiwu Kebon Healthcare Co., Ltd. | China | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL COTTON ROLL | 5 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Prehma Cotton Rolls | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Manufacturer | — | 2 | 2026 |
| Lakong Medical Devices Co., Ltd. | China | Foreign exporter | Dental cotton roll, saliva absorbent | 2 | 2026 |
| Premium Plus International Limited | Hong Kong SAR China | Foreign exporter | Cotton Rolls | 3 | 2017 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Cotton Roll | 3 | 2007 |
| Hager Worldwide, Inc. | United States | Manufacturer | Quick Clip | 2 | 2005 |
| Sotera Health LLC | United States | Contract manufacturer | Dental Medical Devices · L FZUSS 0005 R07201 FBB {FIRST AID STER USP ROLL 1/2OZ} · L FZUSS 0040 R02401 FBB {FIRST AID STER USP ROLL 4OZ/24} · L FZUSS 0040 R02401 RT {RITE AID STER USP ROLL 4 OZ/24} · +15 | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA 1-1/2" x 3/8" #2 Medium Cotton Rolls, Non-Woven | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | COTTON ROLLS · DENTAL COTTON ROLLS · dental gauze · NON WOVEN SPONGE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Cotton Roll | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | COTTON ROLL | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Nonsterile Cotton Rolls | — | — |
| Daiso USA LLC | United States | Foreign exporter | Teflon Floss & Pick 40P WHITE x 40 PCs. | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Cotton Rolls | — | — |
| SPS/Crosstex International | United States | Manufacturer | Cotton Rolls- Advantage Plus · Cotton Rolls- Premium | — | — |
| Pascal International | United States | Contract manufacturer | Isolator · Mini Isolator | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Cotton roll | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Cotton Rolls Non Sterile | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Retraction Cap | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | — | — | — |
| battech | United States | Repacker / relabeler | dental cotton sponge | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | cotton roll | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Cotton Rolls, cotton roll dispenser, cotton roll applicators | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Cotton Roll | — | — |
| Hager & Werken | Germany | Contract manufacturer | COTTON CLIPS II | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | Cotton Roll | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | — | — | — |
| Euronda SPA | Italy | Manufacturer | MONOART COTTON ROLLS | — | — |
| Midwest Sterilization Corp. | United States | Contract sterilizer | Cotton, Roll | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tender Corporation d/b/a Adventure Ready Brands | United States | Repacker / relabeler | Cotton Roll | — | — |
| VastMEd LLC | United States | Repacker / relabeler | VASTMED COTTON, ROLL | — | — |
| Vermont Manufacturing Services, Inc. | United States | Repacker / relabeler | Adventure Ready Brands | — | — |
| Zhejiang Medicines & Health Products Import & Expo | China | Foreign exporter | Absorbent Cotton Wool · Cotton Balls · Cotton Roll | — | — |
| Avaline Medical NJ Limited Liability Company | United States | Repacker / relabeler | Large 1 lb White 100% Cotton Roll · Vakly Dental Cotton Balls | — | — |
| Gauke International Trading Co., Ltd. | China | Foreign exporter | Cotton · Cotton Ball · Cotton Roll · Zig-Zag Cotton Roll | — | — |
| Hefei Haixi Trading Co., Ltd. | China | Repacker / relabeler | Cotton nose bleed plugs | — | — |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | Foreign exporter | COTTON, ROLL | — | — |
| Kentron Health Care, Inc. | United States | Manufacturer | KENTEX PREMIUM COTTON ROLL | — | — |
| MB Regentox Vietnam Trading Service Company Limited | Vietnam | Private-label distributor | REGENTOX COTTON, REGENTOX COTTON BUD, REGENTOX MAKE UP REMOVER PAD | — | — |
| Nanjing J SUN Healthcare Co.,Ltd | China | Foreign exporter | Cotton roll/cotton ball | — | — |
| Rece International Corp. | United States | Repacker / relabeler | ViaMed Cotton Roll | — | — |
| Shanghai Dynamic Medical Supplies Co., Ltd. | China | Foreign exporter | COTTON, ROLL | — | — |
| Shanghai Neo-Medical Import & Export Co., Ltd. | China | Foreign exporter | Cotton Roll | — | — |
| Suzhou Hengxiang Imp. & Exp. Co., Ltd. | China | Foreign exporter | Cotton Balls,Cotton Rolls,Cotton Strings,Cotton Pleats,Dental Cotton Rolls | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Anji Fangyuan Sanitary Material Co., Ltd. | China | Repacker / relabeler | COTTON, ROLL | — | — |
| Anji Hongli Import & Export Co.,Ltd | China | Foreign exporter | Cotton Rolls; Dental Cotton Rolls; Zigzag Cotton | — | — |
| Atlas Medical Products LLC | United States | Repacker / relabeler | ROSPITAL PRODUCTOS MEDICOS | — | — |
| Biotronix Healthcare Industries Inc. | United States | Repacker / relabeler | Biotronix Healthcare Cotton Roll | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Changzhou Hualian Health Dressing Co.,Ltd. | China | Foreign exporter | Cotton nose bleed plugs | — | — |
| LA Smile Supply Inc. | United States | Repacker / relabeler | Cotton roll | — | — |
| Nanning TECBOD Biological Technology Co.,Ltd | China | Foreign exporter | Cotton ball, Cotton roll | — | — |
| Surgi-Pak, Inc. | United States | Repacker / relabeler | Burn Gauze | — | — |
| Suzhou DYNAREX Co., Ltd | China | Foreign exporter | COTTON BALL | — | — |
| Wenzhou Zhusi Medical Supplies Co., Ltd | China | Foreign exporter | Wenzhou Zhusi Medical Cotton Roll | — | — |
| Cardinal Health 200, LLC | United States | Manufacturer | — | — | — |
| Dongguan Ellian Enterprise, LTD. | China | Foreign exporter | — | — | — |
| Guangzhou Kaiheng K&S Co.,Ltd. | China | Contract sterilizer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Medinova Group Co. | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Suzhou Deinerays Trading Co., Ltd. | China | Foreign exporter | — | — | — |
| Suzhou Virgil Medical Technology Co., Ltd. | China | Contract sterilizer | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 4 Dec 1987 | K872810 | STRUNG DENTAL ROLLS | American Silk Sutures, Inc. |
| 30 Apr 1987 | K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Medgroup Enterprises, Inc. |
| 27 Oct 1986 | K863764 | COTTON ROLLS, NON-STERILE | The Medical Group, Inc. |
| 6 Aug 1986 | K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | Intl. Verbandstoff-Fabrik Schaffhau |
| 10 Jul 1986 | K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | Cross Country Paper Products Corp. |
| 23 May 1985 | K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | Molnlycke A/S Hospital Products |
| 3 Jul 1984 | K841327 | DENTAL COTTON ROLLS | Intl. Verbandstoff-Fabrik Schaffhau |
| 3 Feb 1984 | K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. |
| 18 Feb 1983 | K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Veratex Corp. |
| 23 Oct 1981 | K812709 | STERILE DENTAL ROLL | Medspec Corp. |
| 14 Apr 1981 | K810830 | HOYT COTTON ROLLS | Hoyt Laboratories |
| 23 Oct 1980 | K802429 | COTTON ROLLS | Worldwide Surgical Gauze |
| 6 Dec 1979 | K792391 | COTTON ROLL COMPRESSION CAPS | Parker Laboratories, Inc. |
| 14 Jan 1977 | K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. |
Official records: FDA product classification for EFN · 21 CFR 872.6050.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026