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Data / Medical devices / Bur, Surgical, General & Plastic Surgery

Bur, Surgical, General & Plastic Surgery (GFF): 101 FDA-registered makers in 13 countries

101 establishments in 13 countries are registered with the FDA to make Bur, Surgical, General & Plastic Surgery (product code GFF, Class 1, 21 CFR 878.4820). 2 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on July 6, 1998, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
GFF
Device class
1
Regulation
878.4820
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States52
Germany17
Switzerland7
Pakistan6
China5
United Kingdom4
France3
Ireland2
South Korea1
Mexico1
Taiwan1
Japan1
Brazil1

Makers of Bur, Surgical, General & Plastic Surgery

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
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer3August 22, 1994010api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1July 6, 1998000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
ACURATA GMBH & CO. KGaAThurmansbang Bavaria, GermanyManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
American MedicalsJacksonville, FL, United StatesSpecification developer0000api.fda.gov
Aplus (guangzhou) Medical Technology CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Arthrex GmbHMunich Bavaria, GermanySpecification developer0000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & M Precision, Inc.Ruskin, FL, United StatesContract manufacturer0000api.fda.gov
Bien-Air Surgery SALe Noirmont Jura, SwitzerlandManufacturer0000api.fda.gov
Bioaccess, Inc.Baltimore, MD, United StatesSpecification developer0000api.fda.gov
BUSCH & CO. GmbH & Co. KGENGELSKIRCHEN North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
CnS MEDICAL CO., LTD.Pocheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
De Soutter Medical Ltd.ASTON CLINTON Buckinghamshire, United KingdomManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.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
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
HPC MedxHanover, PA, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
In2Bones SASSaint-Priest Rhone, FranceExporter to the US, Specification developer0010api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Vision Plus Medical Technology Co.,ltdNanchang Jiangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jota AGRUETHI, SG Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lasco Diamond Products, Inc.Chatsworth, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Lukas-Erzett GMBH & Co. KGEngelskirchen North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0010api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Manufacturing Technology And Services, LLCOxford, AL, United StatesContract manufacturer0000api.fda.gov
Maxxos-Medical GMBHMahlstetten Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0010api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Microware Precision Co., Ltd.Taichung, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanManufacturer0000api.fda.gov
Neoortho Produtos Ortopedicos S/ACuritiba Parana, BrazilManufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Nuell, Inc.Leesburg, IN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Omega Surgical Instruments, Inc.Flint, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orthopedic Sciences, IncOverland Park, KS, United StatesSpecification developer0000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer0000api.fda.gov
Ortho Solutions UK LimitedMaldon Essex, United KingdomManufacturer0000api.fda.gov
PB Swiss Tools AGGruenen Bern, SwitzerlandManufacturer0000api.fda.gov
PB Swiss Tools AGWasen/Bern, SwitzerlandManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
PrecxisPeillonnex Haute-Savoie, FranceContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Robinson Healthcare LimitedWorksop Nottinghamshire, United KingdomManufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Selenium Medical S.A.S.La Rochelle Charente-Maritime, FranceContract manufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tritex Medical Manufacturing LLCMount Morris, MI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Velocity Orthopedics, Inc.Rancho Cucamonga, CA, United StatesManufacturer0000api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zonefly Medical Devices Co., Ltd.Danyang Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated July 6, 1998. 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.