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 · 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
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).
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.
- 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.
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 | 🔒 Unlock all 336 records → | ||
| Karl Storz Se & Co Kg | 🔒 Unlock all 336 records → | ||
| Universal Brain Inc. | 🔒 Unlock all 336 records → | ||
Browse 35 more matching record reports
- Smith & Nephew Medical Ltd
- Karl Storz Se & Co Kg
- Universal Brain Inc.
- Covidien
- Sxwell USA LLC
- Butterfly Network, Inc.
- Roche Molecular Systems, Inc.
- Endologix LLC
- Datex-Ohmeda, Inc.
- Siemens Healthcare Diagnostics Inc.
- SunMed Group Holdings, LLC
- MC3, Inc.
- Aesthetic Protools, Inc.
- Sight Sciences, Inc.
- Endure Industries, Inc.
- Dexcom, Inc.
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
- GE Medical Systems Information Technologies, Inc.
- GE Medical Systems Information Technologies, Inc.
- Teleflex Medical LLC
- Healgen Scientific LLC
- Medtronic Sofamor Danek USA, Inc.
- Icu Medical, Inc.
- Icu Medical, Inc.
- Greystone Medical, LLC
- LifeSignals, Inc.
- AngioDynamics, Inc.
- Kaz USA, Inc., A Helen of Troy Company
- Synthes (USA) Products LLC
- Ethicon, Inc.
- Ray Vision Inc.
- Osteomni Inc
- Icp, Inc.
- Fx Shoulder Solutions Inc.
- Neurofield, Inc.
Which related categories and locations should I check?
Browse by establishment role
Manufacturer (1173) Contract manufacturer (527) 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)
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