- [Home](/) › - [DeviceEstablishmentPulse](/v/deviceestablishmentpulse) › - [Hubs](/hub/deviceestablishmentpulse) › - Specification developer (outsources manufacturing) # DeviceEstablishmentPulse: Specification developer (outsources manufacturing) **336 deviceEstablishmentPulse: Specification developer (outsources manufacturing) 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 Boston Scientific Corporation with 2. Data last updated 2026-10-28; each record links to its official source and a full report.** Data as of 2026-10-28 · [Compiled by Zalwin](/research/deviceestablishmentpulse) from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) Copy citation Download all 336 deviceEstablishmentPulse: Specification developer (outsources manufacturing) (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?role=spec_developer) 336 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-18. Most frequent: Boston Scientific Corporation (2). 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). **Search, filter and export DeviceEstablishmentPulse records** [Run instant live search with these filters](/v/deviceestablishmentpulse?role=spec_developer&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/deviceestablishmentpulse/records.csv?role=spec_developer) 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 336 Most frequent - Boston Scientific Corporation (2) - Covidien (2) - GE Medical Systems Information Technologies, Inc. (2) - Icu Medical, Inc. (2) - Ascensia Diabetes Care US Inc. (2) ## How do I get new deviceEstablishmentPulse: Specification developer (outsources manufacturing) by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/deviceestablishmentpulse?role=spec_developer) [Watch this exact filter](/v/deviceestablishmentpulse?role=spec_developer#more-ways) [See alert plans](/v/deviceestablishmentpulse#pricing) ## What are the top deviceEstablishmentPulse: Specification developer (outsources manufacturing) 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 | 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 | | 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 | | 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 | | Ge Medical Systems, LLC | Specification developer (outsources manufacturing) | 3 | System, Nuclear Magnetic Resonance Imaging; System, Planning, Radiation Therapy Treatment; Radiological Image Processing Software For Radiation Therapy | | Align Technology, Inc. | Specification developer (outsources manufacturing) | 3 | Light Transmission Caries Detector; Aligner, Sequential; Orthodontic Software | | Orthopediatrics, Corp | Specification developer (outsources manufacturing) | 5 | File; Plate, Fixation, Bone; Screw, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Elevator, Surgical, General & Plastic Surgery | | Sol-Millennium Medical, Inc. | Specification developer (outsources manufacturing) | 8 | Bandage, Elastic; Dressing, Wound, Drug; Bandage, Liquid, Skin Protectant; Syringe, Piston; Low Dead Space Piston Syringe; Needle, Hypodermic, Single Lumen | | Wright Medical Technology, Inc. | Specification developer (outsources manufacturing) | 5 | Filler, Bone Void, Calcium Compound; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Orthopaedic Surgical Planning And Instrument Guides; Ankle Arthroplasty Implantation System; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | | Arthrex, Inc. | Specification developer (outsources manufacturing) | 12 | Screw, Fixation, Bone; Fastener, Fixation, Biodegradable, Soft Tissue; Staple, Fixation, Bone; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Elbow, Hemi-, Radial, Polymer; System, Facet Screw Spinal Device | | Deka Research & Development Corp. | Specification developer (outsources manufacturing) | 4 | Controller, Infusion, Intravascular, Electronic; Set, Administration, Intravascular; Insulin Pump Secondary Display; Alternate Controller Enabled Insulin Infusion Pump | | Glownar Aesthetics. LLC | Specification developer (outsources manufacturing) | 10 | Brush, Dermabrasion, Powered; Powered Laser Surgical Instrument; Electrosurgical, Cutting & Coagulation & Accessories; Low Power Electrosurgical Devices For Skin Lesion Destruction; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Microneedle Device; Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne | | Boston Scientific Corporation | Specification developer (outsources manufacturing) | 8 | Catheter, Continuous Flush; System, Imaging, Pulsed Echo, Ultrasonic; Computer, Blood-Pressure; Computer, Diagnostic, Programmable; Transducer, Ultrasonic, Diagnostic; Catheter, Ultrasound, Intravascular; System, Image Processing, Radiological | | Olympus Medical Systems Corp. | Specification developer (outsources manufacturing) | 20 | Endoscope, 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 | | Smith & Nephew Medical Ltd | Included in the full CSV with every column 🔒 Unlock all 336 records → | | Karl Storz Se & Co Kg | Included in the full CSV with every column 🔒 Unlock all 336 records → | | Universal Brain Inc. | Included in the full CSV with every column 🔒 Unlock all 336 records → | Browse 35 more matching record reports - [Smith & Nephew Medical Ltd](/report/deviceestablishmentpulse/smith-and-nephew-medical-ltd-hull-east-riding-of-yorkshire-gb--fdaest-8043484-2026-10-07) - [Karl Storz Se & Co Kg](/report/deviceestablishmentpulse/karl-storz-se-and-co-kg-tuttlingen-baden-wurttemberg-de--fdaest-3014342096-2026-09-28) - [Universal Brain Inc.](/report/deviceestablishmentpulse/universal-brain-inc-palo-alto-ca--fdaest-3038896098-2026-09-19) - [Covidien](/report/deviceestablishmentpulse/covidien-lafayette-co--fdaest-2936999-2026-09-18) - [Sxwell USA LLC](/report/deviceestablishmentpulse/sxwell-usa-llc-new-york-ny--fdaest-3013388459-2026-09-14) - [Butterfly Network, Inc.](/report/deviceestablishmentpulse/butterfly-network-inc-burlington-ma--fdaest-3010102386-2026-09-11) - [Roche Molecular Systems, Inc.](/report/deviceestablishmentpulse/roche-molecular-systems-inc-pleasanton-ca--fdaest-3004141078-2026-09-10) - [Endologix LLC](/report/deviceestablishmentpulse/endologix-llc-santa-rosa-ca--fdaest-3008011247-2026-09-09) - [Datex-Ohmeda, Inc.](/report/deviceestablishmentpulse/datex-ohmeda-inc-waukesha-wi--fdaest-3036470679-2026-09-09) - [Siemens Healthcare Diagnostics Inc.](/report/deviceestablishmentpulse/siemens-healthcare-diagnostics-inc-tarrytown-ny--fdaest-2432235-2026-08-27) - [SunMed Group Holdings, LLC](/report/deviceestablishmentpulse/sunmed-group-holdings-llc-grand-rapids-mi--fdaest-1314417-2026-08-26) - [MC3, Inc.](/report/deviceestablishmentpulse/mc3-inc-dexter-mi--fdaest-3011468686-2026-08-26) - [Aesthetic Protools, Inc.](/report/deviceestablishmentpulse/aesthetic-protools-inc-scottsdale-az--fdaest-3043846025-2026-08-24) - [Sight Sciences, Inc.](/report/deviceestablishmentpulse/sight-sciences-inc-menlo-park-ca--fdaest-3010363671-2026-08-24) - [Endure Industries, Inc.](/report/deviceestablishmentpulse/endure-industries-inc-homer-ny--fdaest-3013187142-2026-08-11) - [Dexcom, Inc.](/report/deviceestablishmentpulse/dexcom-inc-san-diego-ca--fdaest-3004753838-2026-08-10) - [GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC](/report/deviceestablishmentpulse/ge-medical-systems-ultrasound-and-primary-care-diagnostics-waukesha-wi--fdaest-3032008018-2026-08-10) - [GE Medical Systems Information Technologies, Inc.](/report/deviceestablishmentpulse/ge-medical-systems-information-technologies-inc-wauwatosa-wi--fdaest-3012359877-2026-08-06) - [GE Medical Systems Information Technologies, Inc.](/report/deviceestablishmentpulse/ge-medical-systems-information-technologies-inc-waukesha-wi--fdaest-3001570235-2026-08-06) - [Teleflex Medical LLC](/report/deviceestablishmentpulse/teleflex-medical-llc-morrisville-nc--fdaest-3011137372-2026-07-31) - [Healgen Scientific LLC](/report/deviceestablishmentpulse/healgen-scientific-llc-houston-tx--fdaest-3009238284-2026-07-29) - [Medtronic Sofamor Danek USA, Inc.](/report/deviceestablishmentpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--fdaest-1030489-2026-07-27) - [Icu Medical, Inc.](/report/deviceestablishmentpulse/icu-medical-inc-san-clemente-ca--fdaest-2025816-2026-07-22) - [Icu Medical, Inc.](/report/deviceestablishmentpulse/icu-medical-inc-lake-forest-il--fdaest-3013319212-2026-07-21) - [Greystone Medical, LLC](/report/deviceestablishmentpulse/greystone-medical-llc-waterford-mi--fdaest-3015176887-2026-07-20) - [LifeSignals, Inc.](/report/deviceestablishmentpulse/lifesignals-inc-milpitas-ca--fdaest-3010552191-2026-07-17) - [AngioDynamics, Inc.](/report/deviceestablishmentpulse/angiodynamics-inc-marlborough-ma--fdaest-1000523114-2026-07-16) - [Kaz USA, Inc., A Helen of Troy Company](/report/deviceestablishmentpulse/kaz-usa-inc-a-helen-of-troy-company-marlborough-ma--fdaest-3006169981-2026-06-23) - [Synthes (USA) Products LLC](/report/deviceestablishmentpulse/synthes-usa-products-llc-west-chester-pa--fdaest-3008812560-2026-06-17) - [Ethicon, Inc.](/report/deviceestablishmentpulse/ethicon-inc-raritan-nj--fdaest-3017102971-2026-06-02) - [Ray Vision Inc.](/report/deviceestablishmentpulse/ray-vision-inc-lake-forest-ca--fdaest-3013436538-2026-05-27) - [Osteomni Inc](/report/deviceestablishmentpulse/osteomni-inc-miami-fl--fdaest-3041915189-2026-05-22) - [Icp, Inc.](/report/deviceestablishmentpulse/icp-inc-green-bay-wi--fdaest-2132509-2026-05-21) - [Fx Shoulder Solutions Inc.](/report/deviceestablishmentpulse/fx-shoulder-solutions-inc-addison-tx--fdaest-3014128390-2026-05-14) - [Neurofield, Inc.](/report/deviceestablishmentpulse/neurofield-inc-santa-barbara-ca--fdaest-3010900508-2026-05-05) More records in this hub: [page 2](/hub/deviceestablishmentpulse/role/spec-developer/page/2) · [page 3](/hub/deviceestablishmentpulse/role/spec-developer/page/3) [Browse all DeviceEstablishmentPulse record reports](/hub/deviceestablishmentpulse/records) ## Which related categories and locations should I check? ### Browse by establishment role [Manufacturer (1173)](/hub/deviceestablishmentpulse/role/manufacturer) [Contract manufacturer (527)](/hub/deviceestablishmentpulse/role/contract-manufacturer) [Repackager or relabeler (192)](/hub/deviceestablishmentpulse/role/repackager) [Foreign exporter (155)](/hub/deviceestablishmentpulse/role/foreign-exporter) [Other (93)](/hub/deviceestablishmentpulse/role/other) [Contract sterilizer (91)](/hub/deviceestablishmentpulse/role/contract-sterilizer) [Remanufacturer (3)](/hub/deviceestablishmentpulse/role/remanufacturer) ### Browse by u.s. or foreign [Foreign establishment (1379)](/hub/deviceestablishmentpulse/place/foreign) [U.S. establishment (1191)](/hub/deviceestablishmentpulse/place/domestic) ### Browse by u.s. state [California (284)](/hub/deviceestablishmentpulse/state/ca) [Illinois (95)](/hub/deviceestablishmentpulse/state/il) [Florida (84)](/hub/deviceestablishmentpulse/state/fl) [Indiana (73)](/hub/deviceestablishmentpulse/state/in) [Massachusetts (70)](/hub/deviceestablishmentpulse/state/ma) [Texas (68)](/hub/deviceestablishmentpulse/state/tx) [New York (56)](/hub/deviceestablishmentpulse/state/ny) [New Jersey (49)](/hub/deviceestablishmentpulse/state/nj) [Pennsylvania (44)](/hub/deviceestablishmentpulse/state/pa) [Georgia (43)](/hub/deviceestablishmentpulse/state/ga) [Minnesota (43)](/hub/deviceestablishmentpulse/state/mn) [Ohio (42)](/hub/deviceestablishmentpulse/state/oh) [Delaware (37)](/hub/deviceestablishmentpulse/state/de) [Colorado (33)](/hub/deviceestablishmentpulse/state/co) [North Carolina (33)](/hub/deviceestablishmentpulse/state/nc) [Utah (32)](/hub/deviceestablishmentpulse/state/ut) [Tennessee (27)](/hub/deviceestablishmentpulse/state/tn) [Michigan (25)](/hub/deviceestablishmentpulse/state/mi) [Wisconsin (23)](/hub/deviceestablishmentpulse/state/wi) [Arizona (15)](/hub/deviceestablishmentpulse/state/az) [Connecticut (14)](/hub/deviceestablishmentpulse/state/ct) [Maryland (14)](/hub/deviceestablishmentpulse/state/md) [South Carolina (14)](/hub/deviceestablishmentpulse/state/sc) [New Hampshire (12)](/hub/deviceestablishmentpulse/state/nh) [Alabama (11)](/hub/deviceestablishmentpulse/state/al) [Missouri (11)](/hub/deviceestablishmentpulse/state/mo) [Nevada (10)](/hub/deviceestablishmentpulse/state/nv) [Virginia (10)](/hub/deviceestablishmentpulse/state/va) [Washington (10)](/hub/deviceestablishmentpulse/state/wa) [Oregon (9)](/hub/deviceestablishmentpulse/state/or) [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: Specification developer (outsources manufacturing) are listed? 336 records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-18. ### Can I get alerts for Specification developer (outsources manufacturing)? 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)