Data / Medical devices / Perforator, Ear-Lobe
Perforator, Ear-Lobe (JYS): 16 FDA-registered makers in 9 countries
16 establishments in 9 countries are registered with the FDA to make Perforator, Ear-Lobe (product code JYS, Class 1, 21 CFR 874.4420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 17, 1986, and lists 0 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
- JYS
- Device class
- 1
- Regulation
- 874.4420
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 4 |
| United States | 4 |
| China | 2 |
| Sweden | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
| India | 1 |
| Hong Kong | 1 |
Makers of Perforator, Ear-Lobe
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 |
|---|---|---|---|---|---|---|---|---|
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blomdahl Medical AB | Halmstad Halland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIME-PACK S. De R.L. De C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRL Manufacturing S.A. | San Pedro de Macoris, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evonos GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, 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 | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiujiang Meite Jewelry Co..Ltd. | Jiujiang Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent-Tech Manufacturers Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meed Skills Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanchang Firstomato Medical Devices Co., Ltd. | Nanchang Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Industries, Inc. | Gardena, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richline Group, Inc. | Tamarac, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 17, 1986. 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.