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

Apparatus, Suction, Single Patient Use, Portable, Nonpowered (GCY): 139 FDA-registered makers in 22 countries

Name: FDA-registered makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

139 establishments in 22 countries are registered with the FDA to make Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY, Class 1, 21 CFR 878.4680). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 96 510(k) clearances under this code, the latest on October 1, 1997, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GCY
Device class: 1
Regulation: 878.4680
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
United States	48
China	47
India	7
Germany	6
Mexico	5
Taiwan	5
South Korea	3
Canada	2
United Kingdom	2
Turkey	2
Israel	1
Pakistan	1
Switzerland	1
Spain	1
Australia	1
Netherlands	1
Argentina	1
Italy	1
France	1
New Zealand	1
Malaysia	1
Vietnam	1

Makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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	Recall events	Source
Axiom Medical, Inc.	Torrance, CA, United States	Manufacturer	1	April 26, 1979	0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	1	December 20, 1978	0	api.fda.gov
Deroyal Industries, Inc.	New Tazewell, TN, United States	Contract manufacturer, Repackager or relabeler	1	December 20, 1978	0	api.fda.gov
Greer Medical, Inc.	Santa Barbara, CA, United States	Specification developer	1	January 28, 1991	0	api.fda.gov
Icu Medical, Inc.	San Clemente, CA, United States	Complaint file establishment, Specification developer	1	May 12, 1994	0	api.fda.gov
Medtronic Perfusion Systems	Minneapolis, MN, United States	Specification developer	1	April 25, 1995	0	api.fda.gov
Medtronic Grand Rapids	Grand Rapids, MI, United States	Manufacturer	1	April 25, 1995	0	api.fda.gov
Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, Mexico	Manufacturer	1	April 25, 1995	0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Complaint file establishment, Specification developer	1	January 30, 1984	1	api.fda.gov
Accumedix, Inc.	Libertyville, IL, United States	Contract manufacturer	0		0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Albert Hohlkoerper GMBH & Co. KG	HEMER North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Anhui Ares Medical Technology Co.,ltd.	Tianchang Anhui, China	Manufacturer	0		0	api.fda.gov
Apothecaries Sundries MFG Pvt Ltd	GURUGRAM Haryana, India	Manufacturer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer, Repackager or relabeler	0		2	api.fda.gov
Acute Ideas Co., Ltd.	Taipei, Taiwan	Contract manufacturer, Manufacturer, Specification developer	0		0	api.fda.gov
Baxter Healthcare Corporation	Round Lake, IL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Baxter Healthcare Corporation	Cleveland, MS, United States	Manufacturer	0		0	api.fda.gov
Beilun Plastech Inc	Ningbo Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
BLS Systems, Ltd.	OAKVILLE Ontario, Canada	Manufacturer	0		0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0		0	api.fda.gov
Border Opportunity Saver Systems, Inc.	Del Rio, TX, United States	Contract manufacturer	0		0	api.fda.gov
Besmed Health Business Corporation	New Taipei City, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
C.R. Bard, Inc.	Covington, GA, United States	Contract sterilizer, Specification developer	0		0	api.fda.gov
Cardinal Health 200, LLC	Jacksonville, TX, United States	Manufacturer	0		0	api.fda.gov
Cardinal Health P.R. 218, Inc.	Anasco, PR, United States	Manufacturer	0		0	api.fda.gov
Changshu Beyond Medical Device Co., Ltd.	Changshu Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Chilecom Medical Devices Co Ltd	Xiangtan Hunan, China	Manufacturer	0		0	api.fda.gov
China Zhong Yan Chang Xing International Co. Ltd	Zibo City Shandong, China	Contract manufacturer	0		0	api.fda.gov
Conmed Corporation	Utica, NY, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Conod Medical Shuyang Co., Ltd.	Shuyang Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	0		0	api.fda.gov
Cardinal Health (Kenmex Medical Specialties)	TIJUANA Baja California, Mexico	Manufacturer	0		0	api.fda.gov
Cardinal Health 200, LLC	El Paso, TX, United States	Manufacturer	0		0	api.fda.gov
Conmed Corporation	Westborough, MA, United States	Specification developer	0		0	api.fda.gov
Conod Medical Co.,Limited	Changshu Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
ConvaTec Limited, GDC Building	Deeside Flintshire, United Kingdom	Specification developer	0		0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	0		0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Degania Silicone, Ltd.	DEGANIA BET Northern, Israel	Manufacturer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	0		0	api.fda.gov
Dmed	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Dekko	Avilla, IN, United States	Contract manufacturer	0		0	api.fda.gov
Dongguan Qing Xi Essentia Industries Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Elmed Instruments (pvt). Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Essentia Industries Ltd.	Dong Guan Guangdong, China	Manufacturer	0		0	api.fda.gov
Fansheng Technology (guangdong) Co., Ltd.	Zhongshan City Guangdong, China	Contract manufacturer	0		0	api.fda.gov
FIRSTAR HEALTHCARE Company Limited (Guangzhou)	Guangzhou Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Fortune Medical Instrument Corp.	Taoyuan City, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Gmi Corporation	Franklin, IN, United States	Contract manufacturer	0		0	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Gloor Ltd.	Burgdorf Bern, Switzerland	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Headstar Medical Products Co., Ltd	New Taipei City, Taiwan	Manufacturer	0		0	api.fda.gov
Henan Aile Industrial Co., Ltd.	zhengzhou Henan, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hersill, S.L.	MOSTOLES (MADRID) Madrid(Province), Spain	Manufacturer	0		0	api.fda.gov
Hospital Equipment MFG. Co.	NOIDA Uttar Pradesh, India	Manufacturer	0		0	api.fda.gov
Huizhou Gold Rose Technology Co.,ltd	huizhou Guangdong, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Repackager or relabeler	0		0	api.fda.gov
Hangzhou Primecare Medical Co.,Ltd.	hangzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hebei Ruinuo Medical Instrument Co Ltd	Shijiazhuang Hebei, China	Manufacturer	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	api.fda.gov
Ic Surgical Inc	Grand Rapids, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.	Konya, Turkey	Manufacturer	0		0	api.fda.gov
Instrumed Surgical	Mississauga Ontario, Canada	Manufacturer	0		0	api.fda.gov
International Medical Research	Balcatta Western Australia, Australia	Manufacturer	0		0	api.fda.gov
Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd.	Jiangmen, Guangdong, China	Manufacturer	0		0	api.fda.gov
Jiangsu Hanheng Medical Technology Co., Ltd	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Keling Medical Appliances Co.,ltd.	Yangzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Mcare Medical Co.,ltd.	Danyang Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Synecoun Medical Technology Co., Ltd.	Taizhou City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Maquiladora De Coahuila S De RL De CV	CUIDAD ACUNA Coahuila, Mexico	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Med Michigan Holdings LLC	Lake Odessa, MI, United States	Manufacturer	0		0	api.fda.gov
MEDIKAN CO., Ltd.	Gangseo-gu Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Meditop BV	Montfoort Utrecht, Netherlands	Manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		0	api.fda.gov
Microtek Medical LLC	Eagan, MN, United States	Specification developer	0		0	api.fda.gov
Microtek Medical LLC	Northfield, IL, United States	Specification developer	0		0	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Neuroenterprises LLC	Chicago, IL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Ningbo Albert Novosino Co., Ltd.	Yuyao Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.	Yuyao Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
Nuk Usa LLC	Reedsburg, WI, United States	Specification developer	0		0	api.fda.gov
O&M Halyard, Inc.	Alpharetta, GA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Odontit SA	BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Omnimate Enterprise Co., Ltd.	Ilan County Yilan, Taiwan	Manufacturer	0		0	api.fda.gov
Philips Oral Healthcare, LLC	Bothell, WA, United States	Specification developer	0		0	api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.	Tuzla Istanbul, Turkey	Exporter to the US, Manufacturer	0		0	api.fda.gov
Poly Medicure Ltd.	Faridabad Haryana, India	Manufacturer	0		0	api.fda.gov
Productos Para El Cuidado De La Salud	NOGALES Sonora, Mexico	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Paras Surgico Factory	Delhi, India	Manufacturer	0		0	api.fda.gov
Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Polybell (Guangzhou) Limited	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Redax S.P.A	Poggio Rusco Mantova, Italy	Manufacturer	0		0	api.fda.gov
Rico Suction Labs, Inc.	Mobile, AL, United States	Manufacturer	0		0	api.fda.gov
Rocket Medical Plc	WASHINGTON Sunderland, United Kingdom	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Rudolf Storz GMBH	EMMINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Sewoon Medical Co., Ltd.	Cheonan-si Chungnam, South Korea	Complaint file establishment, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., Ltd	Heze Shandong, China	Manufacturer	0		0	api.fda.gov
Shantou Chaonan Liangying Hegao Plastic Toy Factory	SHANTOU Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Homed Medical Device Co Ltd	Shenzhen city Guangdong, China	Specification developer	0		0	api.fda.gov
Shenzhen Homed Medical Device Co Ltd	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Kenvox Technology Co., Ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shun Sze Industrial (shenzhen) Co., Ltd	SHENZHEN Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Somavac Medical Solutions, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Stiplastics	Saint Marcellin Isere, France	Manufacturer	0		0	api.fda.gov
Suru International Pvt Ltd	DAHANU Maharashtra, India	Manufacturer	0		0	api.fda.gov
SunMed Group Holdings, LLC	Grand Rapids, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
The Metrix Company	Dubuque, IA, United States	Contract manufacturer	0		0	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Manufacturer	0		0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Think Green Limited	Kumeu Auckland, New Zealand	Manufacturer	0		0	api.fda.gov
Typenex Medical, LLC	Chicago, IL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Unip Plastic Industries Sdn Bhd	CHERAS Selangor, Malaysia	Contract manufacturer	0		0	api.fda.gov
Uresil, LLC	Skokie, IL, United States	Manufacturer	0		0	api.fda.gov
Ustomed Instrumente GMBH & Co. KG	Tuttlingen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
VBM Medizintechnik GMBH	SULZ AM NECKAR Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Vesta	Franklin, WI, United States	Contract manufacturer	0		0	api.fda.gov
Vietnam Lezou Dynamic Company Limited	Viet Tri City Phu Tho, Vietnam	Manufacturer	0		0	api.fda.gov
Well Lead Medical Co. Ltd	GUANGZHOU Guangdong, China	Manufacturer	0		0	api.fda.gov
Well Lead Medical Co. Ltd	GUANGZHOU Guangdong, China	Manufacturer	0		0	api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	Weihai Shandong, China	Manufacturer	0		0	api.fda.gov
Xiamen High Top Electronic Technology Co.,ltd.	Xiamen City Fujian, China	Contract manufacturer	0		0	api.fda.gov
Zhangjiagang New Fellow Med Co., Ltd.	Zhangjiagang Jiangsu, China	Manufacturer	0		0	api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltd	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zibo Dante Co, Ltd	Zibo City Shandong, China	Contract manufacturer	0		0	api.fda.gov
Zimmer Surgical, Inc.	Dover, OH, United States	Manufacturer	0		1	api.fda.gov
iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		0	api.fda.gov

Updated October 1, 1997. 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.