- [Home](/) › - [DeviceEstablishmentPulse](/v/deviceestablishmentpulse) › - [Hubs](/hub/deviceestablishmentpulse) › - Foreign establishment # DeviceEstablishmentPulse: Foreign establishment **1,448 deviceEstablishmentPulse: Foreign establishment are listed from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), dated 2026-05-05 to 2026-10-24; the most frequent is Synergy Health Sterilisation UK Ltd with 4. Data last updated 2026-11-04; each record links to its official source and a full report.** Data as of 2026-11-04 · [Compiled by Zalwin](/research/deviceestablishmentpulse) from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) Copy citation Download the newest 500 deviceEstablishmentPulse: Foreign establishment (CSV) — $4.99 → 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)](/v1/verticals/deviceestablishmentpulse/records.csv?place=foreign) 1,448 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 2026-10-24. Most frequent: Synergy Health Sterilisation UK Ltd (4). Each record links to a full report and the official source. Last updated 2026-11-04. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration). **Search, filter and export DeviceEstablishmentPulse records** [Run instant live search with these filters](/v/deviceestablishmentpulse?place=foreign&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/deviceestablishmentpulse/records.csv?place=foreign) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new DeviceEstablishmentPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/deviceestablishmentpulse) Records 1,448 Most frequent - Synergy Health Sterilisation UK Ltd (4) - Anhui Jbh Medical Apparatus Co., Ltd (2) - Shenzhen Hugemed Medical Technical Development Co., Ltd (2) - Gcmedica Enterprise Ltd.(Wuxi) (2) - Karl Storz Se & Co Kg (2) ## How do I get new deviceEstablishmentPulse: Foreign establishment by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/deviceestablishmentpulse?place=foreign) [Watch this exact filter](/v/deviceestablishmentpulse?place=foreign#more-ways) [See alert plans](/v/deviceestablishmentpulse#pricing) ## What are the top deviceEstablishmentPulse: Foreign establishment right now? | Record | Role | New listings | Devices | |---|---|---|---| | Hong Qiangxing (Shen Zhen) Electronics Limited | Manufacturer | 4 | Pad, Heating, Powered; Stimulator, Electrical, Transcutaneous, For Arthritis; Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning | | Shenzhen Rainbow Light Medical Equipment Co., Ltd | Manufacturer | 4 | Over-The-Counter Powered Light Based Laser For Acne; Light Based Over The Counter Wrinkle Reduction; Lamp, Infrared, Therapeutic Heating | | Anhui Jbh Medical Apparatus Co., Ltd | Manufacturer | 5 | Vehicle, Motorized 3-Wheeled; Wheelchair, Powered | | Shenzhen Hugemed Medical Technical Development Co., Ltd | Manufacturer | 5 | Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Pump, Portable, Aspiration (Manual Or Powered); Stand, Infusion; Dislodger, Stone, Basket, Ureteral, Metal | | Kico Knee Innovation Company | Manufacturer | 9 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Arthroplasty Implantation System; Shoulder Prosthesis, Reverse Configuration | | Guangdong Newdermo Biotech Co., Ltd | Manufacturer | 10 | Lamp, Infrared, Therapeutic Heating; Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne; Pack, Hot Or Cold, Reusable; Stimulator, Transcutaneous Electrical, Aesthetic Purposes | | Stevimed Medical Joint Stock Company | Manufacturer | 21 | Marker, Skin; Wound Dressing Kit; Drape, Surgical, Exempt; Drape, Surgical, Ent; Radiographic Protective Glove; Respirator, Surgical; Drape, Adhesive, Aerosol; Blade, Scalpel; Forceps; Gauze / Sponge,Nonresorbable For External Use | | Gcmedica Enterprise Ltd.(Wuxi) | Manufacturer | 4 | Speculum, Vaginal, Nonmetal; Applicator, Vaginal; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Catheter, Irrigation | | Karl Storz Se & Co Kg | Specification developer (outsources manufacturing) | 17 | Hysteroscope (And Accessories); Endoscope, Neurological; Insufflator, Endoscopic Vessel Harvesting; Insufflator, Laparoscopic; Laryngoscope, Nasopharyngoscope; Laparoscope, General & Plastic Surgery; System, Irrigation, Urological; Nasopharyngoscope (Flexible Or Rigid); Pump, Portable, Aspiration (Manual Or Powered); Insufflator, Hysteroscopic | | Shenzhen Root Innovation Technology Co., Ltd. | Manufacturer | 6 | Pump, Portable, Aspiration (Manual Or Powered); Pump, Breast, Powered; Heater, Perineal, Direct Contact; Shield, Nipple; Lamp, Infrared, Therapeutic Heating | | Kneu Health Limited | Specification developer (outsources manufacturing) | 3 | Transducer, Tremor; Exerciser, Measuring; Reminder, Medication | | Boston Scientific Limited | Manufacturer | 5 | Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Catheter, Continuous Flush; Catheter, Electrode Recording, Or Probe, Electrode Recording; Ureteroscope And Accessories, Flexible/Rigid | | Boston Scientific Limited | Manufacturer | 4 | Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Catheter, Continuous Flush; Hydrogel Spacer | | Tutamen De Mexico, LLC | Manufacturer | 4 | Laser, Comb, Hair; Sleeve, Limb, Compressible; Immunoglobulin G (Igg) Infusion System | | Olympus Medical Systems Corp. | Specification developer (outsources manufacturing) | 20 | Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Narrow Band Spectrum; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Hemostatic Metal Clip For The Gi Tract; Bronchoscope (Flexible Or Rigid); Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Laparoscope, General & Plastic Surgery; Transducer, Ultrasonic, Diagnostic | | Samsung Medison Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 500 records → | | Samsung Medison Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 500 records → | | AIRS Medical Inc. | Included in the full CSV with every column 🔒 Unlock all 500 records → | Browse 35 more matching record reports - [Samsung Medison Co., Ltd.](/report/deviceestablishmentpulse/samsung-medison-co-ltd-gumi-si-gyeongbuk-kr--fdaest-3009758186-2026-10-14) - [Samsung Medison Co., Ltd.](/report/deviceestablishmentpulse/samsung-medison-co-ltd-hongcheon-gun-gangwon-kr--fdaest-8041160-2026-10-14) - [AIRS Medical Inc.](/report/deviceestablishmentpulse/airs-medical-inc-seoul-kr--fdaest-3024820186-2026-10-13) - [Stryker Leibinger GmbH & Co. Kg](/report/deviceestablishmentpulse/stryker-leibinger-gmbh-and-co-kg-freiburg-baden-wurttemberg-de--fdaest-8010177-2026-10-12) - [Ningbo Landing Technology Company Co., Ltd.](/report/deviceestablishmentpulse/ningbo-landing-technology-company-co-ltd-ningbo-zhejiang-cn--fdaest-3031583032-2026-10-12) - [Smith & Nephew Medical Ltd](/report/deviceestablishmentpulse/smith-and-nephew-medical-ltd-hull-east-riding-of-yorkshire-gb--fdaest-8043484-2026-10-07) - [GE Healthcare Japan Corporation](/report/deviceestablishmentpulse/ge-healthcare-japan-corporation-hino-shi-tokyo-jp--fdaest-9612283-2026-10-07) - [Wipro Ge Medical Device Manufacturing Private Limited](/report/deviceestablishmentpulse/wipro-ge-medical-device-manufacturing-private-limited-bangalore-karnataka-in--fdaest-3032109181-2026-10-07) - [Wipro GE Healthcare Private Ltd.](/report/deviceestablishmentpulse/wipro-ge-healthcare-private-ltd-bangalore-karnataka-in--fdaest-9617277-2026-10-07) - [Ge Medical Systems (China) Co., Ltd.](/report/deviceestablishmentpulse/ge-medical-systems-china-co-ltd-wuxi-jiangsu-cn--fdaest-9710602-2026-10-07) - [GE Healthcare Austria GmbH & Co OG](/report/deviceestablishmentpulse/ge-healthcare-austria-gmbh-and-co-og-zipf-oberosterreich-at--fdaest-8020021-2026-10-07) - [Lords Mark Industries Ltd.](/report/deviceestablishmentpulse/lords-mark-industries-ltd-daman-and-diu-dadra-and-nagar--in--fdaest-3039396083-2026-09-30) - [Poly Medicure Ltd.](/report/deviceestablishmentpulse/poly-medicure-ltd-faridabad-haryana-in--fdaest-9616991-2026-09-29) - [Karl Storz Se & Co Kg](/report/deviceestablishmentpulse/karl-storz-se-and-co-kg-tuttlingen-baden-wurttemberg-de--fdaest-3014342096-2026-09-28) - [Warrenslove(Hongkong)limited](/report/deviceestablishmentpulse/warrenslove-hongkong-limited-kowloon-hk--fdaest-3033530347-2026-09-25) - [Medcave Private Limited](/report/deviceestablishmentpulse/medcave-private-limited-sialkot-punjab-pk--fdaest-3021666757-2026-09-24) - [Lakong Medical Devices Co., Ltd.](/report/deviceestablishmentpulse/lakong-medical-devices-co-ltd-dongguan-guangdong-cn--fdaest-3008559238-2026-09-24) - [Shenzhen Hugemed Medical Technical Development Co., Ltd](/report/deviceestablishmentpulse/shenzhen-hugemed-medical-technical-development-co-ltd-shenzhen-guangdong-cn--fdaest-3012797688-2026-09-23) - [Guilin Kevin Peter Technology Co., Ltd.](/report/deviceestablishmentpulse/guilin-kevin-peter-technology-co-ltd-guilin-guangxi-cn--fdaest-3023816720-2026-09-22) - [FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa](/report/deviceestablishmentpulse/fujifilm-corporation-medical-systems-research-and-kashiwa-shi-chiba-jp--fdaest-3018423337-2026-09-22) - [Zhengzhou Youtai Health Technology Co., Ltd.](/report/deviceestablishmentpulse/zhengzhou-youtai-health-technology-co-ltd-zhengzhou-henan-cn--fdaest-3043710338-2026-09-22) - [Zhengzhou Zhongkemei Health Technology Co., Ltd.](/report/deviceestablishmentpulse/zhengzhou-zhongkemei-health-technology-co-ltd-shangjie-district-henan-cn--fdaest-3029328624-2026-09-22) - [FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office](/report/deviceestablishmentpulse/fujifilm-healthcare-manufacturing-corporation-kashiwa-kashiwa-shi-chiba-jp--fdaest-3032109225-2026-09-22) - [Shenzhen Kaiyan Medical Equipment Co., Ltd](/report/deviceestablishmentpulse/shenzhen-kaiyan-medical-equipment-co-ltd-shenzhen-guangdong-cn--fdaest-3011644607-2026-10-23) - [Optik K & R Inc.](/report/deviceestablishmentpulse/optik-k-and-r-inc-toronto-ontario-ca--fdaest-3004145084-2026-10-22) - [Canadian Hospital Specialties Ltd.](/report/deviceestablishmentpulse/canadian-hospital-specialties-ltd-oakville-ontario-ca--fdaest-8022210-2026-10-22) - [Precision Ai PTY Ltd](/report/deviceestablishmentpulse/precision-ai-pty-ltd-brisbane-queensland-au--fdaest-3031914485-2026-10-21) - [New Deantronics Taiwan Ltd.](/report/deviceestablishmentpulse/new-deantronics-taiwan-ltd-new-taipei-city-tw--fdaest-9681191-2026-10-21) - [Synergy Health Sterilisation UK Ltd](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-berkshire-reading-gb--fdaest-3002807310-2026-10-19) - [Synergy Health Sterilisation Uk Ltd](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-daventry-northamptonshire-gb--fdaest-3002807315-2026-10-19) - [Takumi Precision Engineering Ltd](/report/deviceestablishmentpulse/takumi-precision-engineering-ltd-limerick-limerick-county-ie--fdaest-3007189546-2026-10-19) - [Ybrain Inc.](/report/deviceestablishmentpulse/ybrain-inc-daejeon-kr--fdaest-3014389257-2026-10-19) - [Synergy Health Sterilisation UK Ltd](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-berkshire-reading-gb--fdaest-3002807310-2026-10-15) - [Liaoning Dikangyuan Health Technology Co.,Ltd.](/report/deviceestablishmentpulse/liaoning-dikangyuan-health-technology-co-ltd-liaoyang-liaoning-cn--fdaest-3042277608-2026-10-15) - [Synergy Health Westport Ltd](/report/deviceestablishmentpulse/synergy-health-westport-ltd-westport-mayo-ie--fdaest-3010173425-2026-10-14) More records in this hub: [page 2](/hub/deviceestablishmentpulse/place/foreign/page/2) · [page 3](/hub/deviceestablishmentpulse/place/foreign/page/3) · [page 4](/hub/deviceestablishmentpulse/place/foreign/page/4) [Browse all DeviceEstablishmentPulse record reports](/hub/deviceestablishmentpulse/records) ## Which related categories and locations should I check? ### Browse by establishment role [Manufacturer (1225)](/hub/deviceestablishmentpulse/role/manufacturer) [Contract manufacturer (554)](/hub/deviceestablishmentpulse/role/contract-manufacturer) [Specification developer (outsources manufacturing) (354)](/hub/deviceestablishmentpulse/role/spec-developer) [Repackager or relabeler (203)](/hub/deviceestablishmentpulse/role/repackager) [Foreign exporter (169)](/hub/deviceestablishmentpulse/role/foreign-exporter) [Contract sterilizer (103)](/hub/deviceestablishmentpulse/role/contract-sterilizer) [Other (98)](/hub/deviceestablishmentpulse/role/other) [Remanufacturer (3)](/hub/deviceestablishmentpulse/role/remanufacturer) ### Browse by u.s. or foreign [U.S. establishment (1261)](/hub/deviceestablishmentpulse/place/domestic) ### Browse by u.s. state [California (310)](/hub/deviceestablishmentpulse/state/ca) [Illinois (101)](/hub/deviceestablishmentpulse/state/il) [Florida (91)](/hub/deviceestablishmentpulse/state/fl) [Indiana (75)](/hub/deviceestablishmentpulse/state/in) [Massachusetts (73)](/hub/deviceestablishmentpulse/state/ma) [Texas (71)](/hub/deviceestablishmentpulse/state/tx) [New York (58)](/hub/deviceestablishmentpulse/state/ny) [New Jersey (50)](/hub/deviceestablishmentpulse/state/nj) [Pennsylvania (47)](/hub/deviceestablishmentpulse/state/pa) [Minnesota (45)](/hub/deviceestablishmentpulse/state/mn) [Georgia (44)](/hub/deviceestablishmentpulse/state/ga) [Ohio (42)](/hub/deviceestablishmentpulse/state/oh) [Delaware (40)](/hub/deviceestablishmentpulse/state/de) [Utah (35)](/hub/deviceestablishmentpulse/state/ut) [Colorado (34)](/hub/deviceestablishmentpulse/state/co) [North Carolina (33)](/hub/deviceestablishmentpulse/state/nc) [Tennessee (29)](/hub/deviceestablishmentpulse/state/tn) [Michigan (27)](/hub/deviceestablishmentpulse/state/mi) [Wisconsin (27)](/hub/deviceestablishmentpulse/state/wi) [Arizona (17)](/hub/deviceestablishmentpulse/state/az) [South Carolina (16)](/hub/deviceestablishmentpulse/state/sc) [Connecticut (15)](/hub/deviceestablishmentpulse/state/ct) [Maryland (15)](/hub/deviceestablishmentpulse/state/md) [Missouri (14)](/hub/deviceestablishmentpulse/state/mo) [New Hampshire (13)](/hub/deviceestablishmentpulse/state/nh) [Alabama (11)](/hub/deviceestablishmentpulse/state/al) [Nevada (11)](/hub/deviceestablishmentpulse/state/nv) [Oregon (10)](/hub/deviceestablishmentpulse/state/or) [Virginia (10)](/hub/deviceestablishmentpulse/state/va) [Washington (10)](/hub/deviceestablishmentpulse/state/wa) [Kentucky (6)](/hub/deviceestablishmentpulse/state/ky) [Rhode Island (6)](/hub/deviceestablishmentpulse/state/ri) [Louisiana (5)](/hub/deviceestablishmentpulse/state/la) [Idaho (4)](/hub/deviceestablishmentpulse/state/id) [Kansas (4)](/hub/deviceestablishmentpulse/state/ks) [Maine (4)](/hub/deviceestablishmentpulse/state/me) [Nebraska (4)](/hub/deviceestablishmentpulse/state/ne) [South Dakota (4)](/hub/deviceestablishmentpulse/state/sd) [Mississippi (3)](/hub/deviceestablishmentpulse/state/ms) [Oklahoma (3)](/hub/deviceestablishmentpulse/state/ok) ## Frequently asked questions ### How many deviceEstablishmentPulse: Foreign establishment are listed? 1,448 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 2026-10-24. ### 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](/feed/deviceestablishmentpulse.xml) ## Often used together - [FdaApprovalPulse](/v/fdaapprovalpulse) - [FDAPulse](/v/fdapulse) - [TTB Commercial Winery & Brewery Permit Operating Permit Renewal Pulse](/v/ttbbevregrenewpulse) - [StripeCheckoutFrictionAudit](/checkoutfrictionaudit) - [PrivacyHeaderPulse](/privacyheaderpulse) - [SaaSPricingPageDiff](/pricingpagediff)