Data / Medical devices / Curette, Ophthalmic
Curette, Ophthalmic (HNZ): 87 FDA-registered makers in 13 countries
87 establishments in 13 countries are registered with the FDA to make Curette, Ophthalmic (product code HNZ, Class 1, 21 CFR 886.4350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 20, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HNZ
- Device class
- 1
- Regulation
- 886.4350
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Germany | 22 |
| United States | 22 |
| Pakistan | 12 |
| India | 11 |
| China | 8 |
| United Kingdom | 4 |
| France | 2 |
| Slovakia | 1 |
| Belgium | 1 |
| Australia | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
| Hong Kong | 1 |
Makers of Curette, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| Acme Commercial Ways Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Addn Solutions GMBH & Co. KG | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Appasamy Associates Private Limited ( Thruvandar Koil) | Mannadipet Commune Puducherry, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Appasamy Associates Private Limited (MN Kuppam) | Villupuram District Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asanus Medizintechnik GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asol Co.,ltd | huaian Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurora Surgical, LLC | St Petersburg, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amann Medical GmbH & Co. KG | Emmingen-Liptingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&H Surgical Instrument | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bernhard Frey | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bis Mastermed | Kosice Kosicky, Slovakia | Manufacturer, Repackager or relabeler, Specification developer | 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 | Eppelheim Baden-Wurttemberg, Germany | 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 | |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaver-Visitec International, Ltd | BIDFORD-ON-AVON Warwickshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belle Healthcare Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blink Medical LTD | Solihull, United Kingdom | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Teufel GMBH & Co. KG | LIPTINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Choose Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daud Jee MFG Co | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTR Medical Ltd | Swansea, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Duckworth & Kent, Ltd. | BALDOCK Hertfordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epsilon Eye Care Pvt., Ltd. | MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fischer Surgical Inc. | Imperial, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geuder AG | HEIDELBERG Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geuder AG | HEIDELBERG Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hafner Chirurgische Instrumente | BALGHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hasa Optix | Brussels Brussels-Capital Region, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huaian Frimen Co., Ltd | Huaian Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iaa Surgical Instruments Co | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indo-German Surgical Corporation | Mumbai Maharashtra, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inka Surgical Instruments | Jandakot Western Australia, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iscon Surgicals, Ltd. | JODHPUR Rajasthan, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kalson Surgical | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Fenton, MO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Randolph, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kdans Surgical Private Limited | GANDHINAGAR Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mattes Instrumente GMBH | Tuttlingen-Nendingen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moria S.A. | MASSY Hauts-de-Seine, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount Blonck Trading | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Malosa Medical Instruments (Changshu) Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moria S.A | Bourbon l'Archambault Allier, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North American Rescue, LLC. | Greer, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oertel Medical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optego Vision USA, Inc. | Tucson, AZ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul Instruments (india) | CALCUTTA West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pilotis Tech LLC | Brookhaven, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PMS GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sight Sciences, Inc. | Menlo Park, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sihong Ophsurin Co., Ltd | Suqian Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suqian Zhengtong Medical Instruments Co. Ltd | China, Hong Kong | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicon Pvt Ltd | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgiscape | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suru International Pvt Ltd | DAHANU Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tekno Medical Optik-Chirurgie GMBH | TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Total Titanium, Inc. | Red Bud, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WILDmedical GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Surgical Instrument Co. Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 20, 1987. 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.