Blade, Scalpel (GES): 179 FDA-registered makers in 20 countries

Name: FDA-registered makers of Blade, Scalpel
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

179 establishments in 20 countries are registered with the FDA to make Blade, Scalpel (product code GES, Class 1, 21 CFR 878.4800). 1 of them has a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on September 23, 2003, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
United States	52
China	29
Germany	28
Pakistan	21
India	14
South Korea	5
Mexico	5
Japan	5
Taiwan	3
Vietnam	3
Malaysia	2
United Kingdom	2
France	2
South Africa	2
Israel	1
Netherlands	1
Singapore	1
Australia	1
Switzerland	1
Canada	1

Makers of Blade, Scalpel

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
Primrose Medical, Inc.	East Walpole, MA, United States	Manufacturer	1	September 24, 1987	0	api.fda.gov
4 Med Ltd.	Lavon Northern, Israel	Manufacturer	0		0	api.fda.gov
A. Schweickhardt GMBH & Co. KG	Seitingen-Oberflacht Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Acheron Instruments (pvt.) Ltd.	LAHORE Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Aditya Dispomed Products Private Ltd.	Gurgaon Haryana, India	Manufacturer	0		0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Ailee Co., Ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
Anhui Medpurest Medical Technology Co.,ltd	Anqing Anhui, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Anqing Kangmingna Packaging Co.,ltd	Anqing Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Argon Medical Devices Inc.	Athens, TX, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		0	api.fda.gov
Asanus Medizintechnik GMBH	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer	0		0	api.fda.gov
AccuTec, Inc.	Verona, VA, United States	Manufacturer	0		0	api.fda.gov
Aditya Dispomed Products Pvt Ltd.	IMT Manesar Haryana, India	Manufacturer	0		0	api.fda.gov
Apollo Renal Therapeutics, LLC	Ocala, FL, United States	Contract manufacturer	0		0	api.fda.gov
Aspen Surgical Puerto Rico Corp.	Colinas de San Agustin, PR, United States	Manufacturer	0		1	api.fda.gov
Auxein medical Private limited	Sonipat Haryana, India	Manufacturer	0		0	api.fda.gov
B. Braun Medical Industries Sdn. Bhd.	PENANG Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Becton Dickinson	Franklin Lakes, NJ, United States	Specification developer	0		3	api.fda.gov
Beilun Plastech Inc	Ningbo Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
BK Meditech Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0		0	api.fda.gov
Beaver-Visitec International, Inc.	Waltham, MA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, Mexico	Contract manufacturer	0		0	api.fda.gov
Cellpath Ltd	NEWTOWN Powys, United Kingdom	Manufacturer	0		0	api.fda.gov
Central Surgical Co. Pvt. Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Choose Surgical Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.	Luzhu District Taoyuan, Taiwan	Manufacturer	0		0	api.fda.gov
Custom Tube Manufacturing LLC	Yangju-si Gyeonggi, South Korea	Contract manufacturer	0		0	api.fda.gov
Daddy D Pro	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Danyang New Hope Medical Equipment Co., Ltd	Danyang Jiangsu, China	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
Diatrust Medical Co., Ltd.	Nanjing City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Diligent Medical Services	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Dimeda Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Disposafe Health And Life Care Limited	Faridabad Haryana, India	Contract manufacturer, Manufacturer	0		0	api.fda.gov
DR. Frigz International (pvt) Ltd.	SIALKOT, Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Dufner Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
DXM Co., Ltd.	Jeonnam-Gwangju Special Metropolitan City, South Korea	Manufacturer	0		0	api.fda.gov
Denzel Medical GmbH & Co. KG	NEUHAUSEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Exelint International, Co.	Redondo Beach, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Feather Safety Razor Co., Ltd.	Osaka, Japan	Manufacturer	0		0	api.fda.gov
Franko Shehzad Surgico Pvt Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Fischer Surgical Inc.	Imperial, MO, United States	Manufacturer	0		0	api.fda.gov
Geister Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Geotec, Inc.	Warwick, RI, United States	Contract manufacturer	0		0	api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Greens Surgicals Private Limited	Vadodara Gujarat, India	Manufacturer	0		0	api.fda.gov
Guangzhou Aimei Intelligent Technology Co., Ltd.	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guenter Stoffel Medizintechnik GMBH	WURMLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Heinz Kurz GMBH Medizintechnik	DUSSLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hermann Medizintechnik GMBH	FRIDINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Hive International Pvt Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
HMD Healthcare India Pvt. Ltd.	Faridabad Haryana, India	Manufacturer	0		0	api.fda.gov
HONER Medizin-Technik GmbH & Co. KG	SPAICHINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
HRS Instruments, LLC	Tucson, AZ, United States	Manufacturer	0		0	api.fda.gov
Huaian Angel Medical Instrument Co., Ltd	Huaian Jiangsu, China	Manufacturer	0		0	api.fda.gov
Huaian Tisurg Medical Instruments Co., Ltd.	Huaian City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Huaiyin Medical Instruments Co., Ltd.	Huai an City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Humeca BV	Borne Overijssel, Netherlands	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
Hotry Co.,Ltd	Beijing, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
In'tech Medical SAS	RANG DU FLIERS Pas-de-Calais, France	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Integra Microfrance SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France	Manufacturer	0		0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Integra Biotechnical, SA de CV	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0		0	api.fda.gov
Jai Surgicals Ltd.	ALWAR Rajasthan, India	Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Jay-Med	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.	YANGZHOU CITY, Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Jiangsu MJD Medical Technology Co.,ltd.	TAIZHOU Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltd	Tianjin, China	Manufacturer	0		0	api.fda.gov
Kai Industries Co., Ltd.	SEKI CITY Gifu, Japan	Manufacturer	0		0	api.fda.gov
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Katena Products, Inc.	Parsippany, NJ, United States	Specification developer	0		0	api.fda.gov
Katena Products, Inc.	Randolph, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
KLS Martin Se & Co. KG	Fridingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS Martin SE & Co. KG	Muhlheim/Donau Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Ksi Co., Ltd.	Gotemba Shizuoka, Japan	Contract manufacturer	0		0	api.fda.gov
Long Life Surgical Industries	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Mani, Inc. (head Office)	UTSUNOMIYA Tochigi, Japan	Manufacturer	0		0	api.fda.gov
Martech Medical Products S. De RL. De CV.	MEXICALI Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Mason Tayler Medical Products Corp.	Buffalo, NY, United States	Specification developer	0		0	api.fda.gov
Mattes Instrumente GMBH	Tuttlingen-Nendingen Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Med2b Ltd.	Kitzingen Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Medenovate	Irvine, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Medi-Safe Surgicals (pty) Ltd.	Paardevlei Western Cape, South Africa	Specification developer	0		0	api.fda.gov
Medicon, E.G.	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
MEDIPOINT Holdings, LLC	Mineola, NY, United States	Manufacturer	0		0	api.fda.gov
Medipurpose Pte. Ltd.	SINGAPORE Central Singapore, Singapore	Exporter to the US, Foreign private label distributor, Specification developer	0		0	api.fda.gov
Meditec Devices	Vasai(E), Thane, Maharashtra, India	Contract manufacturer	0		0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Meed Skills Surgical	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Specification developer	0		1	api.fda.gov
Meta Dental Corp.	Glendale, NY, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Mount Blonck Trading	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Mani Hanoi Co. Ltd	Thai Nguyen Province, Vietnam	Contract manufacturer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		0	api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Michael Todd Beauty, LP	Port St Lucie, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Muto Pure Chemicals Co., Ltd.	Tokyo, Japan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Nano Surgical, Inc	Delray Beach, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo Zhejiang, China	Exporter to the US, Specification developer	0		0	api.fda.gov
Ningbo Medsun Medical Co., Ltd.	Ningbo Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Nopa Instruments, Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Manufacturer	0		0	api.fda.gov
Otto Ruettgers GMBH & Co. KG	SOLINGEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Paramount Surgimed Ltd.	BHIWADI Rajasthan, India	Manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
PMS GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Precision Engineered Products, Inc.	Taipei, Taiwan	Contract manufacturer	0		0	api.fda.gov
Propper MFG. Co., Inc.	Long Island City, NY, United States	Manufacturer	0		0	api.fda.gov
Planatome, LLC	Phoenix, AZ, United States	Manufacturer, Remanufacturer	0		0	api.fda.gov
Precision Medical Manufacturing LLC	Wheeling, IL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	api.fda.gov
Qlicksmart Pty., Ltd.	WEST END, BRISBANE Queensland, Australia	Exporter to the US, Manufacturer	0		0	api.fda.gov
Quality Concept (pvt) Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Razormed Inc.	GURGAON Haryana, India	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
RC Consolidated Services, Inc	Rancho Cucamonga, CA, United States	Specification developer	0		0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
Ribbel International Ltd.	SONEPAT Haryana, India	Manufacturer	0		0	api.fda.gov
Richard Wolf GMBH	KNITTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Ridge & Crest Company	Monterey Park, CA, United States	Specification developer	0		0	api.fda.gov
Rudolf Medical GMBH + Co. KG	FRIDINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
RZ Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
S & T AG	NEUHAUSEN Schaffhausen, Switzerland	Manufacturer	0		0	api.fda.gov
Selia-Tek Medical Sdn Bhd	Petaling Jaya Selangor, Malaysia	Contract manufacturer	0		0	api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.	Shanghai, China	Manufacturer	0		0	api.fda.gov
Shanghai Youding International Trade Co., Ltd.	Shanghai, China	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Specification developer	0		0	api.fda.gov
Sinapi Biomedical (pty) Ltd	Stellenbosch Western Cape, South Africa	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Smeng Co.,ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
Southmedic, Inc.	BARRIE Ontario, Canada	Manufacturer	0		1	api.fda.gov
Spectra Medical Devices, LLC	Wilmington, MA, United States	Specification developer	0		0	api.fda.gov
Stevimed Medical Joint Stock Company	Can Giuoc Commune Tay Ninh, Vietnam	Manufacturer	0		0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Surgicon Pvt Ltd	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Surgicrafts	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Surgimed Devices	AHMEDABAD Gujarat, India	Manufacturer	0		0	api.fda.gov
Surgiscape	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Surjex	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Suzhou Kyuan Medical Apparatus Co., Ltd.	Suzhou City Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Swann Morton, Ltd.	Sheffield, United Kingdom	Manufacturer	0		0	api.fda.gov
Swissortho LLC	Providence, RI, United States	Specification developer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Sterilance Medical (Suzhou) Inc.	Suzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Surgical Specialties Mexico S DE RL DE CV	Tijuana Baja California, Mexico	Manufacturer	0		0	api.fda.gov
Tekno Medical Optik-Chirurgie GMBH	TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	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
Ustomed Instrumente GMBH & Co. KG	Tuttlingen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Valentine Intl. Ltd.	Hsichih City, Taipei Hsien, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Vien Phat Import Export Service Trading Joint Stock Company	Ben Thanh Ward Ho Chi Minh, Vietnam	Manufacturer	0		0	api.fda.gov
Volgo Care International (private) Limited	Sialkot Punjab, Pakistan	Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0		0	api.fda.gov
Win Wings Corp.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	0		0	api.fda.gov
Weco Manufacturing Group-Henrietta	Rochester, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	Weihai Shandong, China	Manufacturer	0		0	api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	0		0	api.fda.gov
Xodus Medical, Inc.	New Kensington, PA, United States	Specification developer	0		0	api.fda.gov
Yancheng Huida Medical Instruments Co., Ltd	Yancheng Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zepf Medical Instruments GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltd	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0		0	api.fda.gov

Updated September 23, 2003. 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.