Medical device types

A sampling of the types of medical devices on the U.S. market, from electrical stimulators to CPAP and BiPAP machines. Most of these are U.S. Class II devices that require a cleared premarket notification (510(k)) to enable them to be marketed in the United States. And most of them have had a product safety recall or correction.

Read more about medical devices. If you would like to recommend additional devices to add to this page, please let us know.

Navigating the Transition from the QSR to the QMSR

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Medical Device Headlines

EU MDR Compliance Consulting Services

Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our expertise ensures that your products are compliant, safe, and ready for the European market.At Medical Devices...

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Extensions for EU MDR and IVDR Implementation

Initial EU MDR and IVDR transition periods extended  In 2023, the European Union granted an extension for the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by...

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Implementation of the EU MDR and IVDR

A Significant EU Regulatory System Overhaul  The implementation of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represents a significant overhaul of the regulatory framework governing medical devices and...

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FDA Approves XACT Carotid Stent System

A Breakthrough for Stroke Prevention  Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for...

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Medical Devices and Pharmaceuticals

At Medical Devices and Pharma, we specialize in providing top-tier regulatory consulting services tailored to the medical device and pharmaceutical industries. Our deep understanding of policy, laws, regulations, and industry standardsand requirements will ensure your...

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Risks with Exactech Equinoxe Shoulder System 

FDA Safety Communication   April 19 Update:  Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in the defective bags from facilities’ unused inventory. To see if your device is affected by the recall, visit Exactech’s Recall...

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Important Recall Notice for BioMérieux VITEK 2 AST Kit 

Class I Recall Notice   BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk...

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SonarMed Inc Recalls Airway Acoustic Sensors

Urgent Class I Recall Notice   SonarMed Inc. has issued a Class I recall for its Airway acoustic sensors due to a critical issue that could lead to serious health consequences for patients. The U.S. Food and Drug Administration (FDA) has identified this as the most...

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The IMDRF: International Regulators

The International Medical Device Regulators Forum (IMDRF) plays a pivotal role in shaping global regulatory approaches and standards for medical devices, enhancing safety and innovation across international borders.The International Medical Device Regulators Forum...

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FDA Submission and Approval Processes for 510(k)s

Learn how the FDA's 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance.Partner with us to navigate the complexities of the FDA approval process efficiently.The FDA's 510(k) process is...

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