https://lumeadigital.com/
Lumea Digital Pathology | FDA-Cleared Viewer & Lab Solutions
May 8, 2026 - The U.S. leader in primary clinical digital pathology. FDA-cleared viewer, AI-native workflows, and tissue-handling tech trusted by 40% of the U.S. outpatient...
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https://www.cepheid.com/en-US/tests/respiratory/xpert-xpress-cov-2-plus-mc.html
Xpert® Xpress CoV-2 plus (FDA cleared)
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https://epiwatch.com/
EpiWatch® | FDA-Cleared Seizure Detection for Apple Watch
Apr 13, 2026 - EpiWatch® is the first and only FDA-cleared seizure detection app for Apple Watch. Detect tonic-clonic seizures, send real-time alerts to caregivers, and...
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https://higherdose.com/products/higherdose-red-light-face-mask
Red Light Therapy Face Mask - FDA Cleared | HigherDOSE
Boost glow and reduce wrinkles with the HigherDOSE red light face mask—an FDA-cleared red light therapy mask for radiant, youthful skin at home.
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https://www.osteoboost.com/
Osteoboost - FDA-Cleared Vibration Therapy for Low Bone Density
Osteoboost is the first and only FDA-cleared wearable therapy for osteopenia—clinically proven to reduce bone loss in the spine. Order online with prescription.
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https://www.cardiovia.com/
CardioVia – Safe Epicardial Access with FDA-Cleared ViaOne™
CardioVia is transforming epicardial access with ViaOne™ – an FDA-cleared heart device offering precise, and controlled entry to the heart’s surface for...
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https://www.coolerheads.com/
Cooler Heads | Portable FDA-Cleared Scalp Cooling System
Cooler Heads is the creator of Amma™, an FDA-cleared scalp cooling system that helps cancer patients reduce hair loss during chemotherapy. Amma delivers...
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https://www.pureluxtech.com/product-category/hair-growth-series/
Red Light Therapy for Hair Growth | FDA-Cleared Helmets - Pureluxtech
Combat hair thinning with clinically-studied red light therapy. Our hair growth helmets and combs stimulate follicles for thicker, fuller hair. Non-invasive...
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https://fourthfrontier.com/products/frontier-x-plus
Frontier X Plus | FDA-Cleared Medical Grade ECG for Afib Detection
FDA-cleared Frontier X Plus offers continuous ambulatory ECG monitoring with real-time AFib and arrhythmia detection, tracking heart rhythm during daily...
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Natural Water Based Lube, FDA Cleared | Glissant
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iRESTORE Laser Hair Growth System | FDA Cleared | Over 29,000 Reviews – iRESTORE Hair Growth System
Reverse your hair loss in just 3 months with clinically proven technology. Try this best-selling system today with our 365-day trial. See results or send it...
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https://www.currentbody.com/products/currentbody-skin-led-hair-regrowth-device
Red Light Therapy Hair Loss Helmet | FDA Cleared | Hair Growth Laser Cap | CurrentBody
Red light therapy for hair loss and hair growth. Shop the CurrentBody LED hair growth helmet to stimulate follicles and support scalp health for thicker,...
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Amazon.com : NuFACE MINI+ Microcurrent Facial Device Kit - FDA Cleared Face Sculpting & Skin...
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https://elevatepsychiatry.com/treatment-methods/tms/
TMS Therapy Miami | FDA-Cleared Non-Drug Depression Treatment | Elevate Psychiatry
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https://www.cnet.com/health/personal-care/best-red-light-therapy-devices/
Best Red Light Therapy Devices of 2026, Tested and FDA-Cleared - CNET
May 1, 2026 - I tested the most popular red light therapy devices. These are the ones worth your money.
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https://hitconsultant.net/2026/04/15/osteoboost-health-raises-8m-for-fda-cleared-bone-density-device/
Osteoboost Health Raises $8M for FDA-Cleared Bone Density Device
Apr 15, 2026 - Osteoboost Health Secures $8M ed by Ambit Health Ventures to Expand Access to FDA-Cleared Bone Health Device
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https://www.thermoworks.com/products/wand-clinical
WAND Clinical™ - Non-Contact Forehead Thermometer (FDA-Cleared) – ThermoWorks
When a temperature reading could change what you do next — send a child to school, call a doctor, keep someone home — you don’t want “close enough.” You want a...
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Theradome Laser Hair Growth Helmet: FDA-Cleared Hair Device
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https://www.neuxtec.com/
Advanced Neuromuscular Rehabilitation & Performance Systems | FDA-Cleared | NeuX Technologies
Transform your approach to neuromuscular rehabilitation with NeuX Technologies' FDA-cleared iNMS system. Experience clinically-proven results in pain relief,...
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https://truleeevanston.com/the-latest-information-on-fda-cleared-blood-tests-for-alzheimers-disease/
The Latest Information on FDA-Cleared Blood Tests for Alzheimer’s Disease - Trulee Evanston
FDA-cleared blood tests for Alzheimer’s disease represent a major advance in how the condition can be detected and evaluated. These tests measure specific...
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https://www.brainsway.com/our-treatments/
Discover our FDA-Cleared, Deep TMS Treatments | BrainsWay
Jul 3, 2024 - BrainWays unique technology, Deep TMS, is revolutionizing mental illness treatments. Learn more about our noninvasive FDA cleared treatment for MDD and OCD.
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https://www.cionic.com/neuralsleeve
Cionic Neural Sleeve | FDA-Cleared Leg Mobility Device
FDA-cleared Cionic Neural Sleeve improves walking and muscle re-education with real-time leg stimulation, smart adaption, and app control.
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https://www.aidoc.com/learn/clinical-studies/boosting-pulmonary-embolism-detection-with-fda-cleared-ai-uncovering-hidden-cases-in-a-retrospective-study/
Boosting Pulmonary Embolism Detection With FDA-Cleared AI: Uncovering Hidden Cases in a...
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Aluna | Take Control of Your Lung Health - FDA Cleared Spirometer
Aluna's award-winning portable spirometer and app let you measure FEV1 and PEF, track symptoms, log medication intake and export data directly to your doctor.
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https://owletcare.com/
Owlet Baby Monitor: First-of-its-kind FDA-cleared smart baby monitor – Owlet US
Monitor What Matters Most with the First-of-its-kind FDA-cleared smart baby monitor. Dream Sock® is the first-of-its-kind FDA-cleared smart baby monitor to...
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https://earlipointhealth.com/
Autism Diagnostic Device | FDA-Cleared | EarliPoint Health
Discover EarliPoint Health’s FDA-cleared autism diagnostic device using innovative eye-tracking technology delivering earlier insights to support autism care.
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ONE Backdoor Condoms – FDA-Cleared for Anal & Vaginal Use – Kinkly Shop
Explore with confidence using ONE Backdoor Condoms. FDA-cleared for anal and vaginal use, ultra-thin, extra-lubricated, and designed for maximum comfort.
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CipherOx CRI-M1 | Flashback Technologies | FDA-Cleared Blood Loss Monitor
Identify internal bleeding earlier with the CipherOx CRI-M1. Our FDA-cleared AI platform trends acute blood loss using the Compensatory Reserve Index (CRI)....
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https://lumenis.com/aesthetics/treatments/hair-loss/
Non-Surgical FDA Cleared Laser Treatment for Hair Loss - Lumenis
Jan 13, 2026 - FDA-cleared laser treatment for hair loss, designed for clinics and practitioners seeking effective, non-surgical, cutting-edge treatments. Elevate your...
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Oral Herpes Test - FDA-cleared Herpes-1 Test
Our fast, FDA-cleared oral herpes test detects antibodies in the blood. Get tested for oral herpes today, no appointment needed. Fastest Results.
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https://aasm.org/aio-breathe-oral-appliance-fda-cleared-for-pediatric-patients/
AIO Breathe oral appliance FDA cleared for pediatric patients
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FDA-Cleared Laser Caps Regrow Hair in Men & Women – Illumiflow
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Scar Treatment and Scar Reduction With FDA-Cleared embrace®
embrace® medical-grade silicone therapy is clinically proven to help flatten, soften, and fade scars by hydrating scar tissue for a beautiful finish. Shop now.
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SUBRUN Red Light Therapy for Face, FDA-Cleared Red Light Therapy Mask, 336 LEDs Full Face Coverage...
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FDA Cleared AI Powered Decision Support System | dreamed
May 2, 2025 - dreamed has become the first and only company in the world to receive FDA clearance for a decision support system
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https://airsmed.com/en/swiftmr-oemdl/
SwiftMR® with OEM DL solutions: Now FDA 510(k)-Cleared - AIRS Medical Inc.
Apr 28, 2026 - SwiftMR is now FDA-cleared to work alongside OEM deep learning solutions. Reduce MRI scan times further, expand coverage to all sequences and body parts.
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https://spectrumboutique.com/products/playground-naked-love-fda-approved-510k-cleared-water-based-personal-lubricant
Playground Naked Love FDA Approved 510K Cleared Water-Based Personal L
Playground Naked Love FDA Approved 510K Cleared Water-Based Personal Lubricant is designed to offer a soothing, extra-gentle experience for optimal intimate...
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https://www.theverge.com/news/863046/natural-cycles-wristband-digital-birth-control
Natural Cycles launches wristband to replace thermometers for its FDA-cleared birth control app |...
Jan 15, 2026 - The FDA-cleared digital birth control app Natural Cycles is launching a new wristband designed to track your temperature, heart rate, and movement while you...
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https://diagnostics.roche.com/us/en/news-listing/2025/fda-cleared-ptau181-alzheimers-blood-test.html
Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule...
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Amazon.com: HigherDOSE Red Light Face Mask - FDA Cleared LED Red Light Therapy for Face with Near...
Buy HigherDOSE Red Light Face Mask - FDA Cleared LED Red Light Therapy for Face with Near Infrared Technology - At-Home Facial Device to Improve Fine Lines,...
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https://innolitics.com/portfolio/mobius/
We helped build the CBCT module, got it FDA cleared, and supported them through the Varian...
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Tantaly Water Based Sex Lubricant, FDA 510K Cleared
Discover Tantaly water based sex lubricant, one of the best lube for sex dolls, delivering smooth comfort and a good sex lubricant experience
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https://www.medtechdive.com/press-release/20260414-osteoboost-secures-8m-to-expand-access-to-its-fda-cleared-prescription-wea/
Osteoboost Secures $8M to Expand Access to its FDA-Cleared Prescription Wearable for Bone Health |...
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https://www.fda.gov/consumers/consumer-updates/want-quit-smoking-fda-approved-and-fda-cleared-cessation-products-can-help
Want to Quit Smoking? FDA-Approved and FDA-Cleared Cessation Products Can Help | FDA
Smoking cessation products approved or cleared by the FDA are shown to help people quit smoking and can even double your chance of quitting successfully.
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