Data / Medical devices / Laryngoscope, Non-Rigid
Laryngoscope, Non-Rigid (CAL): 48 FDA-registered makers in 11 countries
48 establishments in 11 countries are registered with the FDA to make Laryngoscope, Non-Rigid (product code CAL, Class 1, 21 CFR 868.5530). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on April 6, 1995, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CAL
- Device class
- 1
- Regulation
- 868.5530
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 15 |
| China | 12 |
| Germany | 5 |
| United States | 4 |
| Taiwan | 3 |
| India | 3 |
| Japan | 2 |
| Argentina | 1 |
| Estonia | 1 |
| Czechia | 1 |
| Spain | 1 |
Makers of Laryngoscope, Non-Rigid
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 | |
| Anestek Corp. | Taoyuan City, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Magill Medical Technology Co., Ltd. | Changsha Hunan, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crimson International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecleris SRL | Villa Martelli Buenos Aires, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glorious Mercantile Corp. (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPC Medical Limited | Ghaziabad Uttar Pradesh, India | 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 | |
| Hangzhou Shanyou Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jescope Ltd. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KH Czechia s.r.o. | Chodov Sokolov, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kunststoff Helmbrechts AG | Helmbrechts Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meister Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount Blonck Trading | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opcom Medical Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optomic Espana, S.A. | COLMENAR VIEJO Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Riester GMBH | JUNGINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.G. Manufacturers | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sensorendo Medical Technology (zhuhai) Co., Ltd. | Zhuhai Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SGS Export Intl. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Coreray Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Junyuan Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solatch Sons | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicon Pvt Ltd | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swengg Co | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sanping Image Technology Co., Ltd. | Shenzhen Guangdong, China | 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 | |
| WM&DG | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xi'an Haiye Medical Equipment Co,.ltd. | Xi'an City Shaanxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Wesee Meditech Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang UE Medical Corp. | Xianju Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 6, 1995. 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.