Data / Medical devices / Drill, Dental, Intraoral
Drill, Dental, Intraoral (DZA): 143 FDA-registered makers in 21 countries
143 establishments in 21 countries are registered with the FDA to make Drill, Dental, Intraoral (product code DZA, Class 1, 21 CFR 872.4130). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 25, 1999, and lists 3 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
- DZA
- Device class
- 1
- Regulation
- 872.4130
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| South Korea | 30 |
| United States | 20 |
| China | 20 |
| Germany | 15 |
| Israel | 11 |
| Pakistan | 9 |
| Switzerland | 6 |
| Taiwan | 5 |
| France | 5 |
| Brazil | 4 |
| Italy | 4 |
| Japan | 4 |
| Sweden | 2 |
| Hong Kong | 1 |
| Turkey | 1 |
| Liechtenstein | 1 |
| United Kingdom | 1 |
| Russia | 1 |
| Vietnam | 1 |
| Denmark | 1 |
| Hungary | 1 |
Makers of Drill, Dental, Intraoral
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.B. Dental Devices Ltd | Ashdod Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ACH Medical Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alliance Global Technology Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arnold Tuber Industries | Orchard Park, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bicon, LLC | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Composants Medicaux (BCM) | SAINT BLAISE DU BUIS Isere, France | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Concept Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioloren SRL | SARONNO Varese, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotem Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDM Center Of Excellence Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| COHO Advanced Materials Tech. Co., Ltd. | Luzhu District Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cortex Dental Implants Industries Ltd. | Shlomi Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cowellmedi Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Endodontic Technology LLC | Ormond Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cybermed Inc. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D.S.P. Industrial Eireli Epp | Campo Largo Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Morelli Ltda. | SOROCABA Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalmaster (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentech Corp. | Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentin Implants Technologies Ltd. | Mizpe Aviv Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diaswiss S.A. | NYON Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Arches Inc. | Fountain Valley, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot | zhuhai Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIMPLO Ltd. | Yeonje-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doiff Co., Ltd. | Suncheon-si, Jeollanam-do Jeonnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DPM Usa Corp. | Doral, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dti Implant Systems | Kocaeli, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dunamis Dental Co., Ltd. | Gwangmyeong-si Gyeonggi, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Hahnenkratt GMBH | KOENIGSBACH-STEIN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edenta Etablissement | SCHAANWALD Mauren, Liechtenstein | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FAIRFAX MEDICAL PRODUCTS Ltd | London London, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FKG Dentaire Sarl | LE CRET-DU-LOCLE Neuchatel, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frank Dental GMBH | Gmund Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Funing Meitedental Factory | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garana Industries Private Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Meisinger GMBH | NEUSS North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hans Korea | Paju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Mlush Sanitary Products Co.,ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helmut Zepf Medizintechnik GMBH | SEITINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospimed MFG | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Lusterdent Medical Instrument Co.,Ltd | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ilumi Sciences Inc | Chantilly, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innobiosurg Co., Ltd. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intai Technology Corp. Implants Business Unit | Taichung City, Taiwan | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iq Implants Ltd | Omer Southern, Israel | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Izenimplant Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Izenimplant Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itena Clinical Villepinte | Villepinte Seine-Saint-Denis, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JINTAIK (Yunnan) BIOTECH CO., LTD. | Kunming Yunnan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JJGC Industria e Comercio de Materiais Dentarios SA | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Josef Ganter Feinmechanik GMBH | DAUCHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jota AG | RUETHI, SG Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaiser Precision Co. | Hwaseong Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kazan Medical Instruments Plant | Kazan Tatarstan, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Khoury Dent Ltd Via Kasko K.N Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Dental Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacigrus International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani, Inc. (head Office) | UTSUNOMIYA Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani, Inc. (takanezawa Facility) | SHIOYA Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mctbio | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimecca Co Ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| My Implant Business GMBH | Hamm North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neobiotech Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextcon International | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noga Medical Products Ltd. | SHLOMI Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noris Medical Ltd. | Nesher Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Implants Ltd | Or-Yehuda Tel Aviv, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nti-Kahla GMBH, Rotary Dental Instruments | KAHLA Thuringia, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oco Biomedical | Albuquerque, NM, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseo Scientific, LLC | Dover Township, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossvis Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overfibers S.R.L | IMOLA Bologna, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paltop Advanced Dental Solutions Ltd | Caesarea Central, Israel | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| POINTIMPLANT Co., Ltd | Busan, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Dental USA, Inc. | McHenry, IL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Recherches Techniques Dentaires (R.T.D.) | ST. EGREVE Isere, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhein 83 SRL | BOLOGNA Emilia-Romagna, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ronvig Dental MFG. A/S | DAUGAARD Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ritter Implants GmbH & Co. KG | Biberach Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.G.S. International Ltd | Budapest, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sentronic International Corp. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sewon Medix, Inc. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Dazhou Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Superline Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shurcon Manufacturing Company | Jia Shan Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SKY DENT Corp for dental trading | New York, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Snucone Co., Ltd. | Dalseo-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sphinx Tools Ltd | Derendingen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgikor, LLC | Los Angeles, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sweden & Martina S.P.A. | Due Carrare Padova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Toboom Dental Techonology CO., LTD. | Shanghai, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shinhung MST Co., Ltd. | Wonju Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T.A.G. Medical Products Corporation Ltd | GAATON Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, 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 | |
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| TruAbutment Korea Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uniqa Dental Ltd | Netanya Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Dental Changzhou | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Veridiam, LLC | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WARANTEC Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Win Wings Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zonefly Medical Devices Co., Ltd. | Danyang Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zuga Medical, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 25, 1999. 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.