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Data / Medical devices / Apparatus, Suction, Single Patient Use, Portable, Nonpowered / United States

FDA-registered makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered in the United States: 48 establishments

48 establishments in the United States are registered with the FDA to make Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY). 7 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Product code
GCY
Country
United States

Makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Axiom Medical, Inc.Torrance, CA, United StatesManufacturer1April 26, 1979000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1December 20, 1978000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler1December 20, 1978000api.fda.gov
Greer Medical, Inc.Santa Barbara, CA, United StatesSpecification developer1January 28, 1991000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1May 12, 1994000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1April 25, 1995000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1April 25, 1995000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer, Repackager or relabeler0020api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Cardinal Health 200, LLCJacksonville, TX, United StatesManufacturer0000api.fda.gov
Cardinal Health P.R. 218, Inc.Anasco, PR, United StatesManufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal Health 200, LLCEl Paso, TX, United StatesManufacturer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer0000api.fda.gov
DekkoAvilla, IN, United StatesContract manufacturer0000api.fda.gov
Gmi CorporationFranklin, IN, United StatesContract manufacturer0000api.fda.gov
Ic Surgical IncGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Med Michigan Holdings LLCLake Odessa, MI, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Neuroenterprises LLCChicago, IL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Nuk Usa LLCReedsburg, WI, United StatesSpecification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Rico Suction Labs, Inc.Mobile, AL, United StatesManufacturer0000api.fda.gov
Somavac Medical Solutions, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesContract manufacturer0000api.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
Typenex Medical, LLCChicago, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Uresil, LLCSkokie, IL, United StatesManufacturer0000api.fda.gov
VestaFranklin, WI, United StatesContract manufacturer0000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer0010api.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.