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Data / Medical devices / Cannula, Sinus

Cannula, Sinus (KAM): 39 FDA-registered makers in 9 countries

39 establishments in 9 countries are registered with the FDA to make Cannula, Sinus (product code KAM, Class 1, 21 CFR 878.4800). 3 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on October 7, 2011, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KAM
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States22
Germany5
Pakistan5
India2
Costa Rica1
Denmark1
Australia1
Mexico1
China1

Makers of Cannula, Sinus

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
Acclarent, Inc.Irvine, CA, United StatesSpecification developer1September 28, 2007010api.fda.gov
Boston Medical Products, Inc.Shrewsbury, MA, United StatesManufacturer1May 18, 1993000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer1February 8, 2000000api.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
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Dalent MedicalMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
E. Benson Hood Laboratories, Inc.Pembroke, MA, United StatesManufacturer0000api.fda.gov
Eon Meditech Pvt. Ltd.Surat Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ergodenta ApsTaastrup Hovedstaden, DenmarkContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Holger Bumueller LLCRutherfordton, NC, United StatesContract manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesRepackager or relabeler, Reprocessor0010api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Surgicon Pvt LtdSialkot 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

Updated October 7, 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.