Medical & Healthcare Supplies Manufacturers & Suppliers in United States

Santa Clara, United States

• Applicant to the US FDA for 1 medical devices: GenetiSure Dx Postnatal Assay (K163367, 2017). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Environmental permit for an industrial site · ECHO

Franklin Lakes, United States

Hercules, United States

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 64 medical devices: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664, 2017), Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015, 2017), D-10 Hemoglobin A1c Program (K161687, 2016) +61. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Marlborough, United States

• Registered as a manufacturer · Agencia Estatal de Medicamentos y Tecnologias en Salud
• Applicant to the US FDA for 22 medical devices: SpaceOAR Flex™ System (K262151, 2026), Rezum System (K262460, 2026), LithoVue Elite Digital Flexible Ureteroscope System (K261153, 2026) +19. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Billerica, United States

• Registry ID checks out with the state register · GLEIF Global LEI record

Wilmington, United States

• Market access approved: European Union · TRACES NT
• Environmental permit for an industrial site · ECHO

Charlotte, United States

• Site address listed in a government regulator's register · US EPA Facility Registry Service
• Registered with the U.S. FDA (active, renewed for the current year)

San Diego, United States

• Applicant to the US FDA for 28 medical devices: Stelo Glucose Biosensor System (K262472, 2026), Stelo Glucose Biosensor System (K260935, 2026), Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (K261402, 2026) +25. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US EPA Facility Registry Service

Irvine, United States

• Applicant to the US FDA for 133 medical devices: ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (K254232, 2026), Respiration Rate algorithm (K251326, 2026), Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105, 2026) +130. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US EPA Facility Registry Service

Wilmington, DE, United States

• Registry ID checks out with the state register · GLEIF Global LEI record

Boston, United States

• Applicant to the US FDA for 4 medical devices: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024, 2025), TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858, 2025), Citrated: K, KH, RTH, FFH (K232018, 2024) +1. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Registered with the U.S. FDA (active, renewed for the current year)

Alpharetta, GA, United States

Marlborough, United States

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 3 medical devices: Genius AI Detection 2.0 with CC-MLO Correlation (K230096, 2023), Genius AI Detection 2.0 (K221449, 2022), MAMMOSITE MULTI LUMEN (K092405, 2009). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

San Clemente, CA, United States

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 23 medical devices: OTTO™ Disinfecting Cap (K252006, 2026), ClaveQS™ Bag (K251980, 2026), Rio™ Drug Reconstitution Transfer Device (K243985, 2025) +20. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Westbrook, United States

• Market access approved: European Union · TRACES NT
• Environmental permit for an industrial site · ECHO

San Diego, United States

• Applicant to the US FDA for 6 medical devices: MISEQDX UNIVERSAL KIT 1.0 (DEN130042, 2013), ILLUMINA MISEQDX PLATFORM (DEN130011, 2013), ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (K124006, 2013) +3. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US EPA Facility Registry Service

Acton, United States

• Applicant to the US FDA for 15 medical devices: Omnipod 6 algorithm (K261461, 2026), Omnipod 5 algorithm (K251779, 2025), SmartAdjust™ Technology (K241777, 2024) +12. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Plano, TX, United States

• Registry ID checks out with the state register · GLEIF Global LEI record

Sunnyvale, United States

• Applicant to the US FDA for 180 medical devices: da Vinci Surgical System, Model IS5000 (K261823, 2026), Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702, 2026), da Vinci Surgical System, Model IS5000 (K261824, 2026) +177. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US EPA Facility Registry Service

City of Industry, United States

• Site address listed in a government regulator's register · US FDA device establishment registration
• Registered with the U.S. FDA (active, renewed for the current year)

Irvine, United States

• Registered as a manufacturer · ALIMS
• Places goods on the market (national producer register) · Registre national des producteurs

South Jordan, United States

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 118 medical devices: FlexTract Deflectable-Rotational Dilator Sheath Set (K261310, 2026), PreludeSYNC™ Radial Compression Device (K262086, 2026), StatSeal Disc (K254073, 2026) +115. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Middleton, WI, United States

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

Lansing, United States

• Environmental permit for an industrial site · ECHO
• Registered with the U.S. FDA (active, renewed for the current year)

San Diego, United States

• Applicant to the US FDA for 91 medical devices: Bendini Cloud Application (K233706, 2024), NuVasive AttraX Scaffold (K240507, 2024), NuVasive Modulus-C Interbody System (K223731, 2023) +88. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Registered with the U.S. FDA (active, renewed for the current year)

Waltham, United States

• Applicant to the US FDA for 10 medical devices: Eonis SCID-SMA Kit (DEN200044, 2022), Eonis SCID-SMA kit (K203035, 2022), NeoBase 2 Non-derivatized MSMS Kit (K193103, 2020) +7. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US EPA Facility Registry Service

Waltham, United States

• Registered with the U.S. FDA (active, renewed for the current year)

Dublin, United States

• Registered with the U.S. FDA (active, renewed for the current year)

Kalamazoo, United States

• Applicant to the US FDA for 89 medical devices: Sonopet iQ Ultrasonic Aspirator System (K213824, 2022), Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 (K211490, 2021), Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818, 2020) +86. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Environmental permit for an industrial site · ECHO

Wayne, United States

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 2 medical devices: Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (K241451, 2025), ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652, 2016). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Exton, United States

• Registered with the U.S. FDA as a Contract Manufacturer
• Applicant to the US FDA for 7 medical devices: Vial2Bag Advanced® 20mm Admixture Device (K240940, 2024), NovaGuard SA Pro Safety System (K163511, 2017), Intradermal Adapter (K151777, 2015) +4. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Warsaw, United States

• Applicant to the US FDA for 6 medical devices: G7® Acetabular System (K261453, 2026), Persona Partial Knee (K251834, 2025), Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571, 2025) +3. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Environmental permit for an industrial site · ECHO

Anchorage, United States

United States

• Registered with the U.S. FDA (active, renewed for the current year)

Gurnee, United States

• Places goods on the market (national producer register) · US FDA National Drug Code Directory
• Site address listed in a government regulator's register · US FDA device establishment registration

Littleton, United States

• Registered with the U.S. FDA (active, renewed for the current year)

Montgomery, United States

Ewing, United States

• Registered as a manufacturer · Chemistry
• Applicant to the US FDA for 14 medical devices: Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (K243640, 2025), TROJAN Fire & Ice lubricated male natural rubber latex condom (K221906, 2022), TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant (K221431, 2022) +11. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Oakland, United States

• Environmental permit for an industrial site · ECHO

New York, United States

• Registered as a manufacturer · Chemistry
• Places goods on the market (national producer register) · US FDA National Drug Code Directory

Ronkonkoma, NY, United States

• Registry ID checks out with the state register · GLEIF Global LEI record

Manchester, CT, United States

• Registry ID checks out with the state register · GLEIF Global LEI record

Parsippany, NJ, United States

• Registered with the U.S. FDA (active, renewed for the current year)

Johnson City, TN, United States

New York, United States

• Registered with the U.S. FDA (active, renewed for the current year)

Newburyport, MA, United States

• Registered with the U.S. FDA as a Contract Manufacturer
• Registered with the U.S. FDA (active, renewed for the current year)

Rapid City, United States

Woodbury, United States