Data / Medical devices / Instrument, Cast Removal, Ac-Powered
Instrument, Cast Removal, Ac-Powered (LGH): 32 FDA-registered makers in 10 countries
32 establishments in 10 countries are registered with the FDA to make Instrument, Cast Removal, Ac-Powered (product code LGH, Class 1, 21 CFR 888.5960). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on January 28, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LGH
- Device class
- 1
- Regulation
- 888.5960
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| Germany | 8 |
| United States | 8 |
| India | 5 |
| China | 4 |
| Ireland | 2 |
| United Kingdom | 1 |
| Canada | 1 |
| Poland | 1 |
| Switzerland | 1 |
| South Korea | 1 |
Makers of Instrument, Cast Removal, Ac-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baeramed Instrumente GMBH | SCHWENNINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical inc. | Hickory, NC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| De Soutter Medical Ltd. | ASTON CLINTON Buckinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derma Sciences Canada, Inc | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derma Sciences Nantong Incorporation | DEVELOPMENT Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Disruptive Medtech, LLC | Laramie, WY, United States | Contract manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geister Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Medica Sp.zo.o. | Wroclaw Dolnoslaskie, Poland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Zhengda Medical Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manman Manufacturing Company Private Limited | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, 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 | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oscimed SA | LA CHAUX-DE-FONDS, NE Neuchatel, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Medical, Inc. | HWASEONG-SI Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Medica Promotion Private Limited | Vadodara Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterramed Inc | Weehawken, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Ltd., Instruments Division | CARRIGTWOHILL, CO.CORK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork(County), Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Techtronic Industries Medical | Anderson, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zepf Medical Instruments GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longyou Landmedical Technology Co.,ltd. | longyou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 28, 1994. 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.