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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.

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
CAL
Device class
1
Regulation
868.5530
Medical specialty
Anesthesiology

Makers by country

CountryMakers
Pakistan15
China12
Germany5
United States4
Taiwan3
India3
Japan2
Argentina1
Estonia1
Czechia1
Spain1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Anestek Corp.Taoyuan City, TaiwanSpecification developer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Changsha Magill Medical Technology Co., Ltd.Changsha Hunan, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Crimson InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Ecleris SRLVilla Martelli Buenos Aires, ArgentinaManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
GPC Medical LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Shanyou Medical Equipment Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Jescope Ltd.Taipei, TaiwanManufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Video Endoscopy Estonia OueLaagri Harjumaa, EstoniaContract manufacturer0000api.fda.gov
KH Czechia s.r.o.Chodov Sokolov, CzechiaContract manufacturer0000api.fda.gov
Kunststoff Helmbrechts AGHelmbrechts Bavaria, GermanyContract manufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Meister Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Opcom Medical Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Optomic Espana, S.A.COLMENAR VIEJO Madrid(Province), SpainManufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
S.G. ManufacturersSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sensorendo Medical Technology (zhuhai) Co., Ltd.Zhuhai Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
SGS Export Intl.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shenzhen Coreray Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Junyuan Medical Equipment Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Solatch SonsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shenzhen Sanping Image Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
WM&DGNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Xi'an Haiye Medical Equipment Co,.ltd.Xi'an City Shaanxi, ChinaManufacturer0000api.fda.gov
Zhongshan Wesee Meditech Co., Ltd.Zhongshan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang UE Medical Corp.Xianju Zhejiang, ChinaManufacturer0000api.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.