DeviceEstablishmentPulse: Foreign establishment

1,379 deviceEstablishmentPulse: Foreign establishment are listed from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), dated 2026-05-05 to 2026-10-18; the most frequent is Synergy Health Sterilisation UK Ltd with 3. 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

Free sample: 3 records (CSV)

1,379 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (the 500 newest are listed here), dated 2026-05-05 to 2026-10-18. Most frequent: Synergy Health Sterilisation UK Ltd (3). 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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Records
1,379
Most frequent
  1. Synergy Health Sterilisation UK Ltd (3)
  2. Boston Scientific Limited (2)
  3. Samsung Medison Co., Ltd. (2)
  4. Siemens Healthineers Ltd. (2)
  5. Philips India Limited - Image Guided Therapy Systems Business Unit (2)

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What are the top deviceEstablishmentPulse: Foreign establishment right now?

RecordRoleNew listingsDevices
Boston Scientific LimitedManufacturer5Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Ureteroscope And Accessories, Flexible/Rigid; Catheter, Continuous Flush; Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific LimitedManufacturer4Hydrogel Spacer; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Catheter, Continuous Flush
Tutamen De Mexico, LLCManufacturer4Immunoglobulin G (Igg) Infusion System; Sleeve, Limb, Compressible; Laser, Comb, Hair
Olympus Medical Systems Corp.Specification developer (outsources manufacturing)20Endoscope, Accessories, Narrow Band Spectrum; Bronchoscope (Flexible Or Rigid); Laparoscope, General & Plastic Surgery; Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Transducer, Ultrasonic, Diagnostic; Ultrasound Bronchoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Samsung Medison Co., Ltd.Manufacturer13System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Image Processing, Radiological; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software
Samsung Medison Co., Ltd.Manufacturer13System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Image Processing, Radiological; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software
AIRS Medical Inc.Manufacturer4Automated Radiological Image Processing Software; System, Nuclear Magnetic Resonance Imaging; System, Digital Image Communications, Radiological
Stryker Leibinger GmbH & Co. KgManufacturer5Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Plate, Fixation, Bone; Screw, Fixation, Bone; Plate, Bone
Ningbo Landing Technology Company Co., Ltd.Manufacturer3Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter; Massager, Therapeutic, Electric; Joint, Knee, External Brace
Smith & Nephew Medical LtdSpecification developer (outsources manufacturing)6Negative Pressure Wound Therapy Powered Suction Pump; Dressing, Wound, Drug
GE Healthcare Japan CorporationManufacturer19Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Twister, Brace Setting
Wipro Ge Medical Device Manufacturing Private LimitedManufacturer19System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software; Twister, Brace Setting
Wipro GE Healthcare Private Ltd.Manufacturer19Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Twister, Brace Setting
Ge Medical Systems (China) Co., Ltd.Manufacturer45Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Monitor, St Segment With Alarm; Full-Montage Standard Electroencephalograph; Oximeter, Ear; Detector And Alarm, Arrhythmia
GE Healthcare Austria GmbH & Co OGManufacturer21Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting; System, Image Processing, Radiological; System, Imaging, Pulsed Echo, Ultrasonic
Lords Mark Industries Ltd. 🔒 Unlock all 500 records →
Poly Medicure Ltd. 🔒 Unlock all 500 records →
Karl Storz Se & Co Kg 🔒 Unlock all 500 records →
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Manufacturer (1173) Contract manufacturer (527) Specification developer (outsources manufacturing) (336) Repackager or relabeler (192) Foreign exporter (155) Other (93) Contract sterilizer (91) Remanufacturer (3)

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Frequently asked questions

How many deviceEstablishmentPulse: Foreign establishment are listed?

1,379 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 Foreign 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

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