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        Resources for You (Medical Devices)

Consumers (Medical Devices)

                        
                Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved? Home
          Medical Devices
          Resources for You (Medical Devices)
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          Popular TopicsImages of various hearing aids

                    Hearing Aids
          
          Closeup of doctor and patient hands holding and touching breast implants.

                    Breast Implants
    
          Hands holding CPAP mask assembly. Cleaning CPAP Machines and Accessories.

                    FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
    
          Image of women's midsection - Boby Contouring

                    Aesthetic Devices – Body Contouring, Microneedling, Dermal Fillers
          Medical Device SafetyMedical Device Safety Communications
            The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients.Medical Device Recalls
            FDA uses the term "recall" when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
          Medical Device SafetyConsumer Updates
            From simple items like tongue depressors and bedpans to complex technologies such as pacemakers, surgical implants and prosthetics, learn how FDA-regulated medical devices affect you.
          Medical Device SafetyFemale doctor meeting with female patient and pointing to a gynecological diagram. Making Laparoscopic Power Morcellators Safer.​

                    Making Laparascopic Power Morcellators Safer
          
          Photo of a woman holding silicone breast implants in her hand

                    Allergan Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
          How do I report a problem with a Medical Device?MedWatch
            You are encouraged to file a voluntary report by phone at 1-800-332-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program if you have experienced a problem with a medical device.FDA Consumer Complaint Coordinator
            You may also wish to report adverse reactions or other problems with FDA regulated products. To do so, contact the FDA Consumer Complaint Coordinator for the state in which you reside.
          Consumer Topics A-CAttention Deficit Hyperactivity Disorder (ADHD)Automated External Defibrillators (AEDs)Baby Products with SIDS Prevention ClaimsBiotinBlood Glucose Monitoring DevicesCell PhonesCochlear ImplantsContact Lenses
          Consumer Topics D-ZDermal Fillers (Soft Tissue Fillers)Essure Permanent Birth ControlHearing AidsLasikNasal RinsingPulse Oximeters and Oxygen ConcentratorsTanningWeight-Loss and Weigh-Management Devices
          Resources for YouLearn if a Medical Device has been 510(k) ClearedLearn if a Medical Device has been Recently-ApprovedWhat does FDA regulate?Learn how to report an adverse event to the FDAAdverse Event Reporting on MedWatch Learn
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	Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.

                                                                                  Content current as of:
      02/06/2023Consumers (Medical Devices)                
                          

                        Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
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