https://pubmed.ncbi.nlm.nih.gov/37625896/
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k)...
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the...
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https://www.pharmiweb.com/press-release/2020-02-12/carelight-introduces-line-of-fda-cleared-light-therapy-devices-recognized-industry-leader-joins-sal
Carelight Introduces Line Of FDA-Cleared Light Therapy Devices; Recognized Industry Leader Joins...
CHICAGO, Feb. 12, 2020 /PRNewswire/ -- CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the...
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https://centerlinebiomedical.com/
Centerline Biomedical | FDA Cleared Endovascular Navigation Technology
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https://www.hingehealth.com/product/enso/
Enso: An FDA-cleared, wearable pain relief device
A non-addictive and non-invasive way to calm joint and muscle pain within minutes.
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https://nullfake.com/amazon/us/B0DHZXDFJG/fda-cleared-abs-stimulator-muscle-toner-ems-muscle
FDA Cleared - Abs Stimulator M Review Verification: 0.00% Fake | Grade A Trust Score
AI-powered analysis of FDA Cleared - Abs Stimulator Muscle Toner, EMS Muscle Stimulator, Fitness Belt Ab Workout Equipment reveals 0.00% fake reviews out of 8...
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https://amsterdamaesthetics.com/culture/lovell-and-freespira-increase-access-to-fda-cleared-drug-free-ptsd-treatment-for-veterans-and-military-personnel/
Lovell and Freespira Increase Access to FDA-Cleared, Drug-Free PTSD Treatment for Veterans and...
Jun 27, 2023 - Freespira's at-home medical device shown to reduce or lead to remission of symptoms associated with panic disorder and PTSD in 28 days, now available to...
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https://www.greenlight.guru/blog/fda-clearance-approval-granted
FDA Cleared vs Approved vs Granted for Medical Devices
Ever wonder what FDA cleared vs approved vs granted actually mean? Learn the subtle yet important differences between these regulatory terms.
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https://www.hospimedica.com/critical-care/articles/294809674/fda-cleared-ecg-software-powers-real-time-cardiac-monitoring-at-scale.html
FDA-Cleared ECG Software Powers Real-Time Cardiac Monitoring at Scale - Critical Care -...
FDA-Cleared ECG Software Powers Real-Time Cardiac Monitoring at Scale
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https://homegearcritic.com/product/air-purifier-for-smoke-molekule-air-pro-1000-sq-ft-fda-cleared/
Air Purifier for Smoke - Molekule Air Pro, 1000 Sq Ft, FDA Cleared - Home Gear Critic
Discover the Molekule Air Pro Air Purifier, ideal for spaces up to 1000 sq ft. Effectively eliminates smoke, viruses, bacteria, and mold. FDA cleared for...
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https://www.gyrostim.com/
GyroStim | FDA-Cleared Breakthrough Device for Neurorehabilitation
GyroStim is an FDA-cleared, Breakthrough Medical Device delivering computer-automated multimodal neurorehabilitation, transforming neurological outcomes...
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https://lumenis.com.au/aesthetics/treatments/hair-loss/
Non-Surgical FDA Cleared Laser Treatment for Hair Loss - Lumenis
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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https://backontrac.com/
Back On Trac | FDA-Cleared Spinal Decompression Chair
FDA 510(K) cleared spinal traction chair. Non-surgical back pain relief in 12-minute sessions, patient setup under a minute.
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https://www.investorwire.com/news-articles/heartbeam-inc-nasdaq-beat-fda-cleared-system-provides-momentum-as-company-moves-to-innovate-cardiac-care/
HeartBeam Inc. (NASDAQ: BEAT) FDA-Cleared System Provides Momentum as Company Moves to Innovate...
Aug 6, 2025 - The FDA-cleared HeartBeam system enables patients and physicians to access significant arrhythmia data outside traditional clinical settings. The HeartBeam...
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https://pherdal.com/
PherDal Fertility | Only Sterile FDA Cleared At Home Insemination Kit – PherDal Fertility Science
PherDal is the only Sterile FDA cleared at home insemination kit. This patented fertility treatment is for anyone trying to conceive. Home IUI Alternative.
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https://www.prnewswire.com/news-releases/ph-d-feminine-health-launches-first-fda-cleared-phase-3-clinical-trial-for-boric-acid-suppositories-302528102.html
pH-D Feminine Health Launches First FDA-Cleared Phase 3 Clinical Trial for Boric Acid Suppositories
/PRNewswire/ -- pH-D Feminine Health, announces it has initiated the first randomized, placebo-controlled, double-blinded Phase 3 clinical trial cleared to...
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https://www.ksfr.org/npr-news/2025-05-21/first-fda-cleared-alzheimers-blood-test-could-make-diagnoses-faster-more-accurate
First FDA-cleared Alzheimer's blood test could make diagnoses faster, more accurate | KSFR
May 21, 2025 - The first Alzheimer's blood test cleared by the Food And Drug Administration is poised to change the way doctors diagnose and treat the disease.
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https://us2.ai/
FDA-Cleared AI Echocardiography Software | Us2.ai
Us2.ai delivers FDA-cleared, fully automated echocardiography analysis. From DICOM to structured report in seconds. Book a demo today.
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https://www.bio-beat.com/
FDA Cleared Cuffless Blood Pressure Monitoring | Biobeat
May 4, 2026 - Biobeat offers medical-grade, cuff-less 24h BP tracking. FDA-cleared technology and ensure nighttime data with a clear reimbursement pathway.
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https://innerview.ai/
FDA-Cleared Tech for Measuring Internal Tooth Mobility | InnerView AI
Apr 13, 2026 - InnerView AI is FDA-cleared dental tech that measures internal mobility in teeth, bringing new clinical insight to stability and restoration issues.
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https://www.drugscreens.com/
FDA-cleared | CLIA-waived Drug Testing Kits | DrugScreens
Explore DrugScreens.com for accurate, confidential, FDA-cleared and CLIA-waived Drug testing kits tailored for employers, individuals and healthcare providers.
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https://www.lifesciencemarketresearch.com/videos/amaan-mazhar-modulim
Amaan Mazhar, Modulim - FDA-Cleared SFDI Optical Imaging for Limb Health | LSI USA '25 - Life...
Modulim, a leader in optical imaging technology, specializes in delivering non-invasive, real-time diagnostics solutions to enhance patient care in clinical...
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https://www.brainultimate.com/
Brain Ultimate TMS | FDA-Cleared TMS Device for Depression & OCD | Brain Ultimate
May 12, 2026 - Affordable FDA-cleared TMS therapy device with 24/7 operation. Only system using deionized water cooling. 50+ clinics nationwide.
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https://femtechinsider.com/owlet-babysat-launch/
Owlet Introduces FDA-Cleared BabySat for Enhanced Infant Monitoring | Femtech Insider
Jan 8, 2024 - Owlet, a company specializing in smart infant monitoring technology, has recently launched BabySat, a new FDA-cleared pulse oximetry monitoring system for...
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https://www.tctmagazine.com/3d-systems-full-commercial-fda-cleared-nextdent-jetted-denture-solution/
3D Systems announces full commercial launch of FDA-cleared NextDent Jetted Denture Solution in USA
Nov 27, 2025 - With beta testing now complete, the company is taking orders in the U.S. for the NextDent 300 printer, which will be manufactured in its South Carolina...
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https://owletcare.com/
Owlet Baby Monitor: First-of-its-kind FDA-cleared smart baby monitor – Owlet US
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https://www.vektormedical.com/
Revolutionizing Arrhythmia Care with vMap: FDA-Cleared AI-Based Arrhythmia Mapping Solution
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https://rx.news/rocket-doctor-integrates-fda-cleared-smart-otoscope-into-virtual-care-via-remmie-partnership/
Rocket Doctor Integrates FDA-Cleared Smart Otoscope into Virtual Care via Remmie Partnership
Oct 6, 2025 - This partnership highlights the critical role of integrating connected medical devices with telehealth platforms to advance diagnostic confidence and pa...
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https://www.ophthalmologyweb.com/1315-News/594454-FDA-Cleared-FullRange-SD-OCT-Now-Commercially-Available-in-North-America/?catid=5485
FDA-Cleared FullRange SD-OCT Now Commercially Available in North America | OphthalmologyWeb: The...
FDA-Cleared FullRange SD-OCT Now Commercially Available in North America
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Vitalis | FDA-Cleared Remote SOS Health Monitoring
Secure your family's safety with Vitalis. We provide FDA-cleared remote health monitoring, SOS alerts, and fall detection with 24/7 caregiver connectivity.
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https://hitconsultant.net/2022/03/24/wound-care-solution-aid-injured-ukrainians/
RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians
Mar 24, 2022 - RedDress donates its FDA-cleared blood-clotting wound care solution to Ukraine to help with serious injuries and severe trauma wounds.
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https://erythroslight.com/
Erythros Laser Pro | FDA-Cleared Laser Face Mask
The only wireless FDA-cleared laser mask. 164 medical-grade lasers for visible results in 1 week. Voice-controlled, completely hands-free. 60-day risk-free...
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https://www.selectscience.net/article/worlds-first-fda-cleared-alk-automated-gene-scanner-for-lung-cancer-therapy-selection-available-from-asi
World's First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available...
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https://www.newbeauty.com/view/aviclear-energy-device-for-treatment-of-all-acne-severities
AviClear 101: What to Expect From the First and Only FDA-Cleared Energy Device for the Treatment of...
Aug 11, 2022 - Read AviClear 101: What to Expect From the First and Only FDA-Cleared Energy Device for the Treatment of All Acne Severities on NewBeauty Expert beauty...
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https://plasticsurgerypractice.com/client-objectives/rejuvenation/microneedling-rejuvenation/dermalogica-debuts-pro-pen-its-first-medical-aesthetic-device/
Dermalogica Introduces FDA-Cleared Microneedling System
Apr 29, 2026 - Dermalogica launches FDA-cleared PRO Pen microneedling system for acne scars, expanding into professional in-office treatment devices.
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https://7gadgets.com/2020/01/31/fda-cleared-hair-regrowth-cap-for-men-and-women/154409
FDA Cleared Hair Regrowth Cap for Men and Women
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https://www.wuwf.org/2025-05-21/first-fda-cleared-alzheimers-blood-test-could-make-diagnoses-faster-more-accurate
First FDA-cleared Alzheimer's blood test could make diagnoses faster, more accurate | WUWF
May 21, 2025 - The first Alzheimer's blood test cleared by the Food And Drug Administration is poised to change the way doctors diagnose and treat the disease.
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https://lasercapreviews.com/
Laser Cap Reviews And Comparisons - Helping Your Choose The Best FDA Cleared LLLT Devices
Compare laser cap and laser helmet LLLT hair regrowth devices with our unbiased research and reviews.
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https://www.eliteposturecorrector.com/
Elite Posture Corrector | FDA-Cleared Brace for Pain Relief & Better Posture
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https://www.celluma.asia/
FDA-Cleared LED Light Therapy in Asia | Celluma
Medical-grade LED light therapy for acne, wrinkles, hair growth, pain relief, and body contouring in Asia.
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https://levomedical.com/
Levo Gen 2 Tinnitus Treatment | FDA Cleared | Levomedical
May 19, 2026 - Discover Levo Gen 2, the only FDA De Novo cleared device for tinnitus sound therapy. Safe, effective, and clinically proven tinnitus relief.
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https://molekule.com/
Best Air Purifiers with HEPA | FDA-Cleared | MOLEKULE
Molekule air purifiers with HEPA and PECO filters destroy viruses, pet dander, mold, wildfire smoke, and pollutants. FDA-cleared and allergist-recommended.
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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://airgle.com/
Airgle | FDA-Cleared Class II Medical Devices in Air Purification
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https://pulseofdubai.ae/blog/introducing-withings-scanwatch-2-enhanced-features-and-fda-cleared-afib-detection/
Introducing Withings ScanWatch 2: Enhanced Features and FDA-Cleared Afib Detection - Pulse of Dubai
Aug 31, 2023 - Introducing Withings ScanWatch 2: Enhanced Features and FDA-Cleared Afib Detection Discover Dubai's Pulse: Where Stories Connect - Pulse of Dubai
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https://www.medicaldevice-network.com/news/owlet-infant-monitoring/
Owlet launches two FDA-cleared infant monitoring devices
Jan 9, 2024 - Owlet has launched two medical devices, Dream Sock and BabySat, designed to provide caregivers with real-time health insights for infants.
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https://clpmag.com/diagnostic-technologies/clinical-chemistry/siemens-showcases-fda-cleared-atellica-solution/
Siemens Showcases FDA-Cleared Atellica Solution | Clinical Lab Products
May 18, 2020 - The Atellica Solution combines clinical chemistry and immunoassay analyzers with sample management components to form a scalable system.
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https://isleephst.com/
iSleep Home Sleep Apnea Test | FDA Cleared Results in 48 Hours
Conquer the Day. Slay the Night. Sleep Apnea Solutions.
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https://lp.freespira.com/
Freespira - The only FDA-cleared treatment that can reduce or stop panic attacks and PTSD symptoms...
The only FDA-cleared treatment that can reduce or stop panic attacks and PTSD symptoms at home in just 28 days.
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https://onlybookmarkings.com/story20490499/coolsculpting-technicians-serving-deerfield-beach-offering-fda-cleared-muscle-toning-for-men-and-women-at-our-award-winning-studio
CoolSculpting Technicians serving Deerfield Beach Offering FDA-Cleared Muscle Toning for Men and...
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https://business-news-today.com/emagine-solutions-adds-fda-cleared-faceheart-ai-vitals-scanner-to-journey-pregnancy-app-for-contactless-maternal-health-monitoring/
Emagine Solutions adds FDA-cleared FaceHeart AI vitals scanner to Journey
Jun 25, 2025 - The Journey Pregnancy App from Emagine Solutions Technology now includes FDA-cleared FaceHeart vitals scanner, offering AI-based maternal monitoring via mobile...
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https://www.keikku.health/
Smart Stethoscope & Al Medical Scribe | Keikku FDA-Cleared
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https://sleepapneahometest.com/
Home Sleep Apnea Test | FDA-Cleared, Physician-Reviewed | SleepApneaHomeTest
FDA-cleared home sleep apnea tests with board-certified physician interpretation. Start with our free AI facial scan. Results in 2-3 days. Order online.
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https://www.metamorphosislighttherapy.com/
Metamorphosis Light Therapy | FDA-Cleared Red Light Therapy Devices
FDA-cleared red light therapy devices backed by independent clinical studies. Founded by an attorney. As seen in Forbes, Harper's Bazaar, InStyle, Glamour, and...
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https://www.hinlab.com/
Hinlab - FDA-Cleared Smart Cuffs for Vital Signs Monitoring
FDA-cleared smart cuffs for comfortable monitoring of vital signs in hospital, at home, and in clinical trials. Automatic, wireless, medical-grade tracking.
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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.goodrx.com/healthcare-access/digital-health/fda-capsule-endoscopy-camera
Capsule Endoscopy Camera for Home Use Cleared by FDA - GoodRx
The FDA recently cleared a pill-shaped endoscopy camera for home use. The camera is usually swallowed under medical supervision, but the FDA is now allowing...
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https://www.biospace.com/novaerus-defend-1050-cleared-by-fda-as-510-k-class-ii-medical-device-to-inactivate-and-filter-out-airborne-virus-and-bacteria-for-medical-purposes
Novaerus Defend 1050 Cleared by FDA as 510(k) Class II Medical Device to Inactivate and Filter Out...
Jan 14, 2021 - Novaerus, a WellAir company that delivers clean air solutions to help prevent the spread of infectious outbreaks, announced today that the U.S. Food and Drug...
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https://pharmaphorum.com/news/beyfortus-cleared-fda-rsv-prevention-infants
Beyfortus cleared by FDA for RSV prevention in infants | pharmaphorum
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https://salesandmarketingnetwork.com/news_release_bs.html?pipe=0000ac177000191&ID=2018684&key=Corgenix+Medical
News for Medical Sales Reps: Corgenix AspirinWorks(R) Test Kit Cleared by FDA
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https://www.icthealth.org/news/smart-stethoscope-by-eko-cleared-by-fda
Smart stethoscope by Eko cleared by FDA | ICT&health
Provider of acoustic cardiac monitoring Eko Devices has received FDA clearance for Duo, a smart heart monitor. The device is a combination of a digital...
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https://www.tantaly.com/products/tantaly-silky-smooth-water-based-lubricant-for-vaginal-and-anal-sex
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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