Skip to the page
Get started – free

Data / Medical devices / Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT): 193 FDA-registered makers in 22 countries

193 establishments in 22 countries are registered with the FDA to make Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT, Class 2, 21 CFR 880.6850). 122 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 284 510(k) clearances under this code, the latest on October 22, 2026, and lists 19 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KCT
Device class
2
Regulation
880.6850
Medical specialty
General Hospital

Makers by country

CountryMakers
United States122
Germany21
Switzerland9
France5
China5
Sweden4
Mexico4
Israel3
Taiwan3
Brazil2
Canada2
Spain2
Italy2
Andorra1
Finland1
Turkey1
United Kingdom1
South Africa1
Cambodia1
Poland1
Thailand1
Pakistan1

Makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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
Intuitive Surgical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer for export13February 1, 2019000api.fda.gov
Aesculap, Inc.Center Valley, PA, United StatesComplaint file establishment, Specification developer12March 27, 2020010api.fda.gov
Steris CorporationMentor, OH, United StatesComplaint file establishment, Repackager or relabeler, Specification developer11August 7, 2023000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer10August 23, 2024000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesManufacturer10November 30, 2021000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Contract manufacturer, Manufacturer9March 27, 2020000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer9July 5, 2013000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer9March 11, 2013010api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesManufacturer, Repackager or relabeler, Specification developer8August 18, 2015000api.fda.gov
Case Medical, Inc.Bloomfield, NJ, United StatesManufacturer7June 3, 2026000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer for export, Specification developer7February 1, 2019010api.fda.gov
Innovative Sterilization TechnDayton, OH, United StatesManufacturer6May 1, 2025010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer6January 5, 2011000api.fda.gov
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer5September 8, 2026000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer5September 8, 2026000api.fda.gov
S.I.N. Implant System LtdaSao Paulo, BrazilManufacturer5July 12, 2024000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Specification developer5March 21, 2016000api.fda.gov
STERIS CorporationCleveland, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5March 21, 2016000api.fda.gov
Bahadir Usa LLCCarneys Point, NJ, United StatesContract manufacturer, Manufacturer4March 22, 2024000api.fda.gov
Dentsply IH ABMOLNDAL Vastra Gotaland, SwedenSpecification developer4September 4, 2026000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandComplaint file establishment, Specification developer4June 3, 2026000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer4March 31, 2016000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4March 22, 2024000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer4September 15, 2021000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer, Manufacturer4June 13, 2019000api.fda.gov
Sirona Dental Systems GmbHBensheim Hesse, GermanySpecification developer4September 4, 2026000api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Specification developer3July 31, 2017010api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer3December 22, 2023000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer3March 28, 2014000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Specification developer3September 7, 2016000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer3February 26, 2019000api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer3January 28, 2021010api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3December 28, 2015010api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer3March 28, 2025000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer3March 28, 2025000api.fda.gov
Amcor Flexibles, LLCMundelein, IL, United StatesContract manufacturer, Manufacturer2October 15, 2012000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer2July 17, 2007000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer2August 6, 2020000api.fda.gov
Avinent Implant System S.L.U.Santpedor Barcelona, SpainManufacturer2March 1, 2021000api.fda.gov
Cochlear Bone Anchored Solutions ABMolnlycke Vastra Gotaland, SwedenManufacturer2August 24, 2023000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesManufacturer2July 16, 2024000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer2February 21, 2013000api.fda.gov
ConforMIS, Inc.Wilmington, MA, United StatesSpecification developer2October 25, 2017000api.fda.gov
ContainMed, Inc.Indianapolis, IN, United StatesManufacturer, Repackager or relabeler2December 12, 2023000api.fda.gov
CovidienBoulder, CO, United StatesManufacturer2July 17, 2018000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2July 17, 2018000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer2March 13, 2014000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer2August 2, 2004000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler2August 6, 2020000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer2May 7, 2021000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer2October 15, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer2October 15, 2019000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2June 20, 2025000api.fda.gov
MIS Implants Technologies Ltd.BAR LEV INDUSTRIAL PARK Northern, IsraelManufacturer2February 6, 2026000api.fda.gov
Microline Surgical, IncBeverly, MA, United StatesComplaint file establishment, Manufacturer2May 12, 2016000api.fda.gov
Neotract, Inc.Pleasanton, CA, United StatesSpecification developer2October 22, 2021000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2January 25, 2016000api.fda.gov
Soadco, S.L.Escaldes-Engordany, AndorraManufacturer2December 18, 2024000api.fda.gov
Sweden & Martina S.P.A.Due Carrare Padova, ItalyManufacturer2May 26, 2023000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer, Manufacturer2October 22, 2004000api.fda.gov
Straumann Villeret SAVILLERET Bern, SwitzerlandManufacturer2July 29, 2021000api.fda.gov
T.A.G. Medical Products Corporation LtdGAATON Northern, IsraelManufacturer2August 9, 2010000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2April 14, 2020000api.fda.gov
Wipak OYNASTOLA Etela-Karjala, FinlandManufacturer2February 11, 1998000api.fda.gov
Wipak Packaging (Changshu) co., Ltd.Changshu Jiangsu, ChinaManufacturer2February 11, 1998000api.fda.gov
Alliedstar Medical Equipment Co., Ltd.Ziyang Sichuan, ChinaManufacturer1October 14, 2026000api.fda.gov
Argon Medical Productions & Vertriebs Gesellschaft MBH & Co.Bingen am Rhein Rhineland-Palatinate, GermanyManufacturer1December 20, 2016000api.fda.gov
Aygun Surgical Instruments Co.,inc.Kutlukent, Samsun, TurkeyContract manufacturer, Manufacturer1December 12, 2023000api.fda.gov
Activ Surgical IncBoston, MA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Algram Group LtdPlymouth Devon, United KingdomManufacturer1August 2, 2004000api.fda.gov
Assembly-Tek LLCDayton, OH, United StatesContract manufacturer, Repackager or relabeler1March 13, 2006000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesManufacturer, Specification developer1September 30, 2004000api.fda.gov
Bego Implant Systems GMBH & Co. KGBremen, GermanyManufacturer1February 18, 2021000api.fda.gov
Biotech Dental SASSalon de Provence Bouches-du-Rhone, FranceComplaint file establishment, Manufacturer, Specification developer1November 8, 2021000api.fda.gov
Caldera Medical, Inc.Westlake Village, CA, United StatesRepackager or relabeler, Specification developer1July 20, 2020000api.fda.gov
Crosstex International, Inc.Sharon, PA, United StatesManufacturer1December 22, 1994000api.fda.gov
Crosstex InternationalRush, NY, United StatesRepackager or relabeler, Specification developer1December 22, 1994000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer1February 26, 2026000api.fda.gov
Enviropak LLCPeachtree City, GA, United StatesManufacturer1July 13, 1993000api.fda.gov
Ermis MedTechTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1July 5, 2013000api.fda.gov
Gebr. Schwarz GmbHRottweil Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1December 20, 1994000api.fda.gov
Infinetamed AGSarnen Obwalden, SwitzerlandComplaint file establishment, Manufacturer, Specification developer1February 11, 2025000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer1August 2, 2010000api.fda.gov
Intuitive Surgical, Inc.Peachtree Corners, GA, United StatesManufacturer for export, Repackager or relabeler1February 1, 2019000api.fda.gov
Jewel Precision Sheet Metal & Machining, Inc.Cedar Grove, NJ, United StatesManufacturer1December 9, 2016020api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer1August 2, 2002000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Specification developer1July 6, 2021000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer1April 21, 2017000api.fda.gov
La Ada de AcunaCIUDAD DE ACUNA Coahuila, MexicoManufacturer1February 11, 1998000api.fda.gov
Mastel Surgical Inc.Rapid City, SD, United StatesManufacturer1June 18, 2026000api.fda.gov
Mastel Surgical Inc.Schiller Park, IL, United StatesManufacturer1June 18, 2026000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1August 2, 2002000api.fda.gov
Medipack Medical Packaging MFG. Co.DONGGUAN CITY Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer1December 16, 1999000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1February 26, 2026000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesRepackager or relabeler, Specification developer1May 6, 1997000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer1October 15, 2019000api.fda.gov
NuVasive Specialized Orthopedics, Inc.Audubon, PA, United StatesManufacturer1January 25, 2016000api.fda.gov
Orthopli Corp.Philadelphia, PA, United StatesSpecification developer1August 2, 2010000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer, Manufacturer for export1October 29, 2020000api.fda.gov
Oticon Medical ABAskim Vastra Gotaland, SwedenComplaint file establishment, Manufacturer, Specification developer1September 23, 2014000api.fda.gov
Paragon Implant Company, LLCLas Vegas, NV, United StatesManufacturer1November 14, 2025000api.fda.gov
Paragon Implant MFG., LLCCalabasas, CA, United StatesComplaint file establishment, Manufacturer1November 14, 2025000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 21, 2025000api.fda.gov
Pro-Dex, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Pro-Dex IncTustin, CA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1June 3, 2024000api.fda.gov
RP Medical Inc.Kelowna British Columbia, CanadaExporter to the US, Manufacturer1November 25, 2019000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1December 7, 2010000api.fda.gov
Southern Implants (pty) LtdIRENE Gauteng, South AfricaExporter to the US, Manufacturer1March 2, 2022000api.fda.gov
Sterizign Precision TechnologiesBrunswick, ME, United StatesComplaint file establishment, Manufacturer1February 7, 2018000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesManufacturer1August 2, 2002000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesRepackager or relabeler, Specification developer1September 9, 2008000api.fda.gov
SterCUBE Surgical Systems, LLCGrapevine, TX, United StatesComplaint file establishment, Specification developer1October 20, 2015010api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1January 16, 2025000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesContract manufacturer, Manufacturer, Specification developer1April 14, 1977000api.fda.gov
Talladium Espana, SLLLEIDA Lerida, SpainManufacturer1July 22, 2025000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesManufacturer1August 2, 2002000api.fda.gov
Thompson Surgical Instruments, Inc.Traverse City, MI, United StatesManufacturer, Specification developer1October 16, 2015000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer1October 15, 2019000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1July 5, 2013000api.fda.gov
Vericel CorporationCambridge, MA, United StatesComplaint file establishment, Specification developer1February 7, 2018000api.fda.gov
Z-Systems AGOensingen Solothurn, SwitzerlandManufacturer1March 25, 2021000api.fda.gov
Andersen Industries Co., Ltd.Angsnoul District Kandal, CambodiaContract manufacturer, Contract sterilizer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Amcor Flexibles, CommerceCommerce, CA, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Demant Operations Poland Sp. z o.o.Mierzyn Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Dentsply Implants Manufacturing GmbHHanau Hesse, GermanyContract manufacturer0000api.fda.gov
Egmedical SRLVillafranca Padovana, ItalyContract manufacturer0000api.fda.gov
Empirical Spine, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Especialistas En Esterilizacion Y Envase, S. A. De C. V.Tlalnepantla, Estado de Mexico, MexicoContract manufacturer0000api.fda.gov
Fabtech Precision Sheet Metal, LLCSpokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Hand Biomechanics Lab, Inc.Sacramento, CA, United StatesManufacturer0000api.fda.gov
Hoosier Plastics IncTerre Haute, IN, United StatesContract manufacturer0000api.fda.gov
Hupfer Metallwerke GMBH & Co. KGCoesfeld North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Humphry's Industrial Products IncRochester, NH, United StatesContract manufacturer0000api.fda.gov
Ideate MedicalSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Infinitum Eta Ltd.Petach Tikva Central, IsraelContract manufacturer0000api.fda.gov
Inkutec GMBHBarsbüttel Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Intuitive Surgical Optics GmbHFreiburg Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Lianyungang Anson Non-woven Product Co., Ltd.Lianyungang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
MBM Packaging Labs, IncRogersville, TN, United StatesContract manufacturer0000api.fda.gov
Medartis AGBASEL Basel-Stadt, SwitzerlandManufacturer0000api.fda.gov
Medical Conteneur SASSAINT-SOUPPLETS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Medin Technologies, Inc.Totowa, NJ, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Murui International Co., LtdTaipei City, TaiwanContract manufacturer0000api.fda.gov
Medicom Asia-Pacific Holdings Limited. Taiwan BranchWujie Township Yilan, TaiwanContract manufacturer0000api.fda.gov
Medicom Healthcare (Thailand) Co., Ltd.Tambol Nong Yai Chon Buri, ThailandContract manufacturer0000api.fda.gov
Medicraft IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pacific Hospital Supply Co., LtdTongluo Township Miaoli, TaiwanContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Ram Precision Industries IncDayton, OH, United StatesContract manufacturer0000api.fda.gov
Re:build Tekna, LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Ringele AGPratteln Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Shandong Weigao Orthopaedic Device Co.,ltdweihai Shandong, ChinaContract manufacturer0000api.fda.gov
SPS MedicalCOULOMMIERS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
STERIMED, Inc.Ridgeville, SC, United StatesContract manufacturer0000api.fda.gov
Stoll Metalcraft, Inc.Santa Clarita, CA, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Supreme Screw ProductsPlainview, NY, United StatesManufacturer for export0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
TydenBrooksTallapoosa, GA, United StatesContract manufacturer0000api.fda.gov
United Medical Enterprise, Inc.Thomson, GA, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov

Updated October 22, 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.