DeviceEstablishmentPulse: U.S. establishment
1,191 deviceEstablishmentPulse: U.S. establishment are listed from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-18; the most frequent is Sterigenics U.S., LLC with 8. Data last updated 2026-10-28; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
Includes: Establishment, Role, New listings, Devices, Latest listing, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
1,191 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (the 500 newest are listed here), dated 2026-05-01 to 2026-10-18. Most frequent: Sterigenics U.S., LLC (8). Each record links to a full report and the official source.
Last updated 2026-10-28. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
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- Sterigenics U.S., LLC (8)
- Isomedix Operations Inc. (7)
- Boston Scientific Corporation (6)
- Sterigenics US LLC (6)
- Isomedix Operations, Inc. (4)
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What are the top deviceEstablishmentPulse: U.S. establishment right now?
| Record | Role | New listings | Devices |
|---|---|---|---|
| Alc Enterprises Inc | Specification developer (outsources manufacturing) | 4 | Over-The-Counter Powered Light Based Laser For Acne; Light Based Over The Counter Wrinkle Reduction; Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Stethoscope, Electronic |
| Boston Scientific Corporation | Manufacturer | 10 | Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Catheter, Electrode Recording, Or Probe, Electrode Recording; Ureteroscope And Accessories, Flexible/Rigid; Kit, Nephroscope; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology; Endoscopic Ultrasound System, Gastroenterology-Urology; Catheter, Continuous Flush |
| Inquis Medical, Inc. | Manufacturer | 5 | Aspiration Thrombectomy Catheter; Catheter, Continuous Flush; Apparatus, Autotransfusion |
| Boston Scientific Corporation | Specification developer (outsources manufacturing) | 9 | Ureteroscope And Accessories, Flexible/Rigid; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Endoscopic Ultrasound System, Gastroenterology-Urology; Hydrogel Spacer; Kit, Nephroscope; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology |
| Surgentec LLC | Manufacturer | 15 | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument; Sacroiliac Joint Fixation; Rongeur, Manual; Arthroscope; Cover, Barrier, Protective; Drape, Surgical, Antimicrobial; Ring (Wound Protector), Drape Retention, Internal; Retractor, Self-Retaining, For Neurosurgery; Syringe, Piston |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Manufacturer | 6 | Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Mesh, Surgical, Polymeric; Mesh, Surgical; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Collagen Surgical Mesh Containing Drugs |
| Boston Scientific Corporation | Manufacturer | 24 | Powered Laser Surgical Instrument; Ureteroscope And Accessories, Flexible/Rigid; Catheter, Continuous Flush; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); System, Imaging, Pulsed Echo, Ultrasonic; Computer, Blood-Pressure; Computer, Diagnostic, Programmable; Transducer, Ultrasonic, Diagnostic; Hydrogel Spacer; Catheter, Ultrasound, Intravascular |
| Beacon Biosignals, Inc. | Manufacturer | 3 | Standard Polysomnograph With Electroencephalograph; Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| SHOULDER INNOVATIONS, Inc | Specification developer (outsources manufacturing) | 7 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Shoulder Prosthesis, Reverse Configuration |
| Davol Inc., Sub. C.R. Bard, Inc. | Specification developer (outsources manufacturing) | 3 | Mesh, Surgical, Polymeric; Mesh, Surgical, Absorbable, Abdominal Hernia; Surgical Film |
| Endovascular Engineering, Inc. | Manufacturer | 3 | Thrombectomy Whole Blood Return System; Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Continuous Flush |
| Piraeus Medical, Inc. | Manufacturer | 4 | Wire, Guide, Catheter; Guide, Wire, Catheter, Neurovasculature; Catheter, Percutaneous; Catheter, Percutaneous, Neurovasculature |
| MEDLINE INDUSTRIES, LP - Northfield | Specification developer (outsources manufacturing) | 144 | Wrap, Sterilization; Visual, Pregnancy Hcg, Prescription Use; Drink, Glucose Tolerance; Suture, Nonabsorbable, Synthetic, Polyethylene; Pediatric Position Holder; Helicobacter Pylori; Set, Administration, Intravascular; Regulator, Vacuum; System, Blood Collection, Vacuum-Assisted, Manual; Chair And Table, Medical |
| Paragon 28 | Manufacturer | 9 | Kit, Surgical Instrument, Disposable; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Staple, Fixation, Bone; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone; Screw, Fixation, Bone |
| Abyrx, Inc. | Manufacturer | 7 | Wax, Bone; Methyl Methacrylate For Cranioplasty; Cover, Burr Hole |
| Ge Parallel Design, Inc. | 🔒 Unlock all 500 records → | ||
| Ge Medical Systems, LLC | 🔒 Unlock all 500 records → | ||
| INNO Holdings Inc. | 🔒 Unlock all 500 records → | ||
Browse 35 more matching record reports
- Ge Parallel Design, Inc.
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- FUJIFILM Healthcare Americas Corporation
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- Orthopediatrics, Corp
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- Balt USA, LLC
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- Arthrex, Inc.
- Millyard Advanced Medical Products LLC
- PROCEPT BioRobotics Corporation
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- Glownar Aesthetics. LLC
- Biomet, Inc.
- Amarigo Inc
- Depuy Orthopaedics, Inc.
- Masimo Corporation
- Boston Scientific Corporation
- Boston Scientific Corporation
- Boston Scientific Corporation
- NGInstruments, Inc dba Avalign Cutting Instruments
- Millstone Medical Outsourcing LLC
- Isomedix Operations Inc.
- Tecomet Inc.
- Isomedix Operations, Inc
- Biopro, Inc.
- Isomedix Operations, Inc.
More records in this hub: page 2 · page 3 · page 4
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Frequently asked questions
How many deviceEstablishmentPulse: U.S. establishment are listed?
1,191 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (the 500 newest are shown on this page), last refreshed automatically. The most recent is dated 2026-10-18.
Can I get alerts for U.S. establishment?
Yes. DeviceEstablishmentPulse can email you new records matching this filter; plans are listed on the DeviceEstablishmentPulse page.
Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Informational only. RSS feed of new records