Data / Medical devices / Stylet, Surgical, General & Plastic Surgery
Stylet, Surgical, General & Plastic Surgery (GAH): 70 FDA-registered makers in 18 countries
70 establishments in 18 countries are registered with the FDA to make Stylet, Surgical, General & Plastic Surgery (product code GAH, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on April 22, 2011, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GAH
- Device class
- 1
- Regulation
- 878.4800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 27 |
| Germany | 13 |
| Pakistan | 5 |
| South Korea | 5 |
| Malaysia | 4 |
| China | 2 |
| France | 2 |
| Switzerland | 2 |
| Sweden | 1 |
| South Africa | 1 |
| Australia | 1 |
| Mexico | 1 |
| Finland | 1 |
| Ireland | 1 |
| India | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
| Brazil | 1 |
Makers of Stylet, Surgical, General & Plastic Surgery
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 |
|---|---|---|---|---|---|---|---|---|
| 3D Instrumentation Sdn Bhd | Bukit Mertajam Pulau Pinang, Malaysia | Contract 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 | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, 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 | |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Laserthermia Systems AB | Lund Skane, Sweden | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Coba Biomedical Pty (ltd) | Bloemfontein Free State, South Africa | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Orthopedic | Gastonia, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FHC, Inc. | Bowdoin, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Field Orthopaedics | Teneriffe Queensland, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gsource, LLC. | Emerson, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hans Biomed Corp. | Daejeon, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ilg Medizintechnik GMBH | DURCHHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Microfrance SAS | SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ispg, Inc. | Lakewood Ranch, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, Germany | Contract 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 | |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mectalent Ltd. | Oulu Kainuu, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metapharm Co., Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miraclus Orthotech Private Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MK medical GmbH | Emmingen-Liptingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medartis Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ohdae Corporation | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | 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 | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudischhauser Surgical Instruments Manufacturing GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Xinzhengyu Technology Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinntech Medical (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMT Schilling Metalltechnik GMBH | MUHLHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spineguard, SA | Vincennes Paris, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swengg Co | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares Ltda | Rio Claro Sao Paulo, Brazil | 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 | |
| Vorzeigen | Connersville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc. | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weba Medizintechnik GMBH & Co. | BALGHEIM Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 22, 2011. 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.