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Data / Medical devices / Excavator, Ear

Excavator, Ear (JYH): 36 FDA-registered makers in 9 countries

36 establishments in 9 countries are registered with the FDA to make Excavator, Ear (product code JYH, Class 1, 21 CFR 874.4420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JYH
Device class
1
Regulation
874.4420
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States12
Germany9
Pakistan7
United Kingdom2
China2
New Zealand1
India1
France1
Mexico1

Makers of Excavator, Ear

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
Adept Medical LtdAuckland, New ZealandManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DTR Medical LtdSwansea, United KingdomManufacturer0000api.fda.gov
Evonos GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Harf IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Robinson Healthcare LimitedWorksop Nottinghamshire, United KingdomManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.