Reach device makers the month they bring a new product to the U.S.
DeviceEstablishmentPulse tracks 2,570 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), last refreshed 2026-10-28, for medical device contract manufacturers and sterilization providers, ISO 13485 and FDA QMS consultants, regulatory and U.S. agent service firms, component, packaging and labeling suppliers, and med-tech distributors looking for new product lines. Search, filter and preview free; CSV unlocks, alerts and API access start at $4.99. Every record links to its official source.
A new FDA device listing means a product is about to ship: it needs contract manufacturing, sterilization, QMS and regulatory support, packaging, labeling and distribution. See who listed what, and where they are.
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Long-tail intelligence feed for medical device contract manufacturers and sterilization providers, ISO 13485 and FDA QMS consultants, regulatory and U.S. agent service firms, component, packaging and labeling suppliers, and med-tech distributors looking for new product lines
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
Score is a heuristic estimate, not advice.
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✓ Live public data, refreshed 2026-10-28 · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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Top DeviceEstablishmentPulse records
- Titanlinks Logistics LLC (repackager or relabeler, Newark, D — 336
- Millstone Medical Outsourcing LLC (contract manufacturer, Ol — 272
- Soher Med Limited (foreign exporter, Hong Kong, HK) — 257
- Icu Medical, Inc. (specification developer, San Clemente, CA — 223
- MEDLINE INDUSTRIES, LP - Northfield (specification developer — 144
Latest top-scored records
| 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 |
Browse by establishment role
Manufacturer (1173) Contract manufacturer (527) Specification developer (outsources manufacturing) (336) Repackager or relabeler (192) Foreign exporter (155) Other (93) Contract sterilizer (91) Remanufacturer (3)
Browse by u.s. or foreign
Foreign establishment (1379) U.S. establishment (1191)
Browse by u.s. state
California (284) Illinois (95) Florida (84) Indiana (73) Massachusetts (70) Texas (68) New York (56) New Jersey (49) Pennsylvania (44) Georgia (43) Minnesota (43) Ohio (42) Delaware (37) Colorado (33) North Carolina (33) Utah (32) Tennessee (27) Michigan (25) Wisconsin (23) Arizona (15) Connecticut (14) Maryland (14) South Carolina (14) New Hampshire (12) Alabama (11) Missouri (11) Nevada (10) Virginia (10) Washington (10) Oregon (9) Kentucky (6) Rhode Island (6) Louisiana (5) Idaho (4) Kansas (4) Maine (4) Nebraska (4) South Dakota (4) Mississippi (3) Oklahoma (3)
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.