# Medical Device Expansions FDA Clears Teleflex Incorporated's QuikClot Control+™ Hemostatic Device By Kalin Ned | Published 2025-04-30 | Tech Source: Trend Hunter, https://www.trendhunter.com/trends/teleflex-incorporated References: [globenewswire](https://www.globenewswire.com/news-release/2025/04/30/3071140/0/en/Teleflex-receives-FDA-510-k-Clearance-for-Expanded-Indications-of-the-QuikClot-Control-Hemostatic-Device.html)  Teleflex Incorporated has achieved a significant regulatory milestone with the [FDA's](https://www.trendhunter.com/trends/nonagon-n9) expanded clearance of its QuikClot Control+™ Hemostatic Device, which is now approved for managing all classifications of internal and external bleeding. Due to this development, surgeons across various specialties gain access to a versatile bleeding control solution with demonstrated effectiveness in both emergency and [elective settings](https://www.trendhunter.com/trends/bloom-2). This development broadens the device's clinical utility beyond its original trauma and surgical applications to include general, [gynecologic, and orthopedic procedures](https://www.trendhunter.com/trends/spark-biomedical). According to Teleflex Incorporated, this may potentially increase the QuikClot Control+™ Hemostatic Device's addressable market by $150 million in the U.S. alone. The clearance was supported by a robust retrospective study involving 603 patients across multiple medical centers. The study demonstrated the product's efficacy across diverse bleeding scenarios. Notably, this marks one of the first instances where real-world evidence has successfully facilitated an FDA indication expansion for a hemostatic device. Image Credit: Teleflex Incorporated ## Trend Insights (Trend Hunter) - Score: 4.9/10 - Popularity: 52% | Activity: 54% | Freshness: 40% - Audience gender: 50% men, 50% women - Primary generations: Millennial, Gen X - Top markets: North America ## Categories [Trend Hunter](https://www.trendhunter.com/trends) > [Tech](https://www.trendhunter.com/tech) > [Science](https://www.trendhunter.com/science) ## Key Themes ### Key Themes Behind This Trend - **Real-world Evidence in Medical Devices:** Leveraging real-world data for FDA submissions could revolutionize the approval process for medical devices, providing a faster route to market. - **Multispecialty Surgical Tools:** The expansion of devices like the QuikClot Control+™ to broader surgical use points to a growing demand for versatile medical instruments that reduce the need for procedure-specific tools. - **Blood Loss Management Innovations:** Innovations in hemostatic devices can significantly advance patient care in both emergency medicine and planned surgeries by improving outcomes and reducing recovery times. ### Where This Applies - **Medical Device Manufacturing:** Ongoing advancements in hemostatic technology underline the industry's potential for rapid growth and transformation as demand for versatile surgical solutions rises. - **Healthcare Regulatory Consulting:** The strategic use of retrospective studies for regulatory approval highlights the increasing importance of expert consulting in navigating complex FDA processes. - **Surgical Equipment Distribution:** The extended use of efficient bleeding control devices across multiple medical fields can drive significant expansion opportunities for distributors with broad healthcare networks. ## Related on Trend Hunter - [Clot-Inducing Synthetic Injectables](https://www.trendhunter.com/trends/synthetic-injectables.md) - [Clinical-Grade Telehealth Exam Systems](https://www.trendhunter.com/trends/nonagon-n9.md) - [Recovery-Optimizing Medical Devices](https://www.trendhunter.com/trends/lung-resection-surgery.md) - [Tech-Enhanced Medical Solutions](https://www.trendhunter.com/trends/bruin-biometrics.md) - [High-Performance Medical Tools](https://www.trendhunter.com/trends/highperformance-medical-tools.md) - [Fish Skin Wound Covers](https://www.trendhunter.com/trends/kerecis.md) - [Advanced Medical Imaging Applications](https://www.trendhunter.com/trends/optive-ai.md) - [Advanced Cardiac Treatment Technologies](https://www.trendhunter.com/trends/cardiac-treatment-technology.md) - [Clinical Skin Rejuvenation Devices](https://www.trendhunter.com/trends/fiber-laser.md)