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,...
neuromuscular rehabilitationperformance systemsfda clearedadvancedneux
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.
fda cleared
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.
tinnitus treatmentfda clearedlevogen
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...
light therapyfda clearedmetamorphosisdevices
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.
fda clearedinternal toothtechmeasuringmobility
https://www.ubergizmo.com/2024/12/osteoboost-fda-cleared/
Osteoboost: FDA-Cleared Wearable For Bone Health Now Available | Ubergizmo
Bone Health Technologies (BHT) has opened pre-orders for Osteoboost, the first FDA-cleared wearable medical device designed to treat osteopenia, a...
fda clearedbone healthnow availablewearableubergizmo
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.
fda clearedvibration therapylowbonedensity
https://www.illumina.com/ko-kr/clinical/diagnostics/cystic_fibrosis.html
Cystic Fibrosis Testing | FDA-cleared IVD platform
FDA-cleared next-generation sequencing panels for detection of causative and clinically relevant variants for cystic fibrosis.
cystic fibrosis testingfda clearedivdplatform
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.
fda clearedfor depressionbrainultimatetms
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.
home sleep apnea testfda clearedphysicianreviewed
https://www.monitoredrx.com/
MTI Respiratory Platform | FDA-Cleared Lung Testing
FDA-cleared respiratory platform uniting validated testing, instant care decisions, and home monitoring. Lab-quality spirometry without the lab.
fda clearedmtirespiratoryplatformlung
https://samsungmobilepress.com/articles/samsung-announces-fda-cleared-irregular-heart-rhythm-notification-for-galaxy-watch
Samsung Announces FDA-Cleared Irregular Heart Rhythm Notification for Galaxy Watch | Samsung Mobile...
The official source for the latest news, stories and media resources on Samsung's smartphones, tablets, PCs, and wearables.
fda clearedheart rhythm
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.
best air purifiersfda clearedhepamolekule
https://nonagon-care.com/
FDA-cleared Telehealth Devices & Remote Physical Exam Kit - Care at Hand
Jul 1, 2025 - Stay on top of your health with Nonagon's FDA-cleared telehealth device and remote physical exam kit that connect you with healthcare providers from home.
fda clearedtelehealth devicesphysical examremote
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.
led light therapyfda clearedin asiacelluma
https://vitalis-pha.com/
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.
fda clearedvitalisremotesoshealth
https://finviz.com/news/344672/labcorp-launches-fda-cleared-fentanyl-test-delivering-results-in-10-minutes
Labcorp Launches FDA-Cleared Fentanyl Test Delivering Results in 10 Minutes
Stock screener for investors and traders, financial visualizations.
fda clearedfentanyl testdelivering resultslabcorplaunches
https://www.healthcaredive.com/news/new-apple-watch-adds-fda-cleared-ecg-application/532204/
New Apple Watch adds FDA-cleared ECG application | Healthcare Dive
The tech giant certainly hasn't hidden its interest in the healthcare market, but Wednesday's announcements clarify that the company is not looking back as it...
new apple watchfda clearedaddsecgapplication
https://www.biospace.com/autonomix-completes-licensing-transaction-for-fda-cleared-ablation-technology
Autonomix Completes Licensing Transaction for FDA-Cleared Ablation Technology - BioSpace
fda clearedcompleteslicensingtransactionablation
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...
cooler headsfda clearedscalp coolingportablesystem
https://www.withings.com/us/en/blood-pressure-monitors
Best Smart Blood Pressure Monitors | FDA-Cleared, HSA/FSA Eligible | Withings USA
Get the most of home blood pressure monitoring with Withings range of easy-to-use, clinically validated smart Blood Pressure Monitors.
blood pressure monitorsfda cleared
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.
back on tracfda clearedspinal decompressionchair
https://bruinbiometrics.com/
Bruin Biometrics | FDA-Cleared Pressure Injury Prevention
Detect PIs 5 days (median) before they’re visible with the only FDA-cleared SEM scanning technology. Protect patients, reduce costs, and eliminate preventable...
fda clearedpressure injurybruinbiometricsprevention
https://www.prnewswire.com/news-releases/biophotas-inc-launches-first-5-mode-battery-powered-fda-cleared-device-302510256.html
BioPhotas, Inc. Launches First 5-Mode, Battery-Powered, FDA Cleared Device
/PRNewswire/ -- Celluma Light Therapy, the global leader in award-winning, clinically backed LED technology, announces the launch of the Celluma NOVA, the...
battery poweredfda clearedinclaunchesfirst
https://www.ubergizmo.com/2024/12/osteoboost-fda-cleared/?taid=6750fed745ae040001adc790
Osteoboost: FDA-Cleared Wearable For Bone Health Now Available | Ubergizmo
Bone Health Technologies (BHT) has opened pre-orders for Osteoboost, the first FDA-cleared wearable medical device designed to treat osteopenia, a...
fda clearedbone healthnow availablewearableubergizmo
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.
drug testing kitsfda clearedcliawaived
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...
fda clearedbreakthroughdeviceneurorehabilitation
https://www.vektormedical.com/
Revolutionizing Arrhythmia Care with vMap: FDA-Cleared AI-Based Arrhythmia Mapping Solution
fda clearedrevolutionizingarrhythmiacarevmap
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...
digital pathologyfda clearedlumeaviewerlab
https://www.prnewswire.com/news-releases/headaterm-2-the-most-affordable-fda-cleared-innovative-otc-anti-migraine-device-302100977.html
HeadaTerm 2: The Most Affordable FDA Cleared Innovative OTC Anti-Migraine Device
/PRNewswire/ -- WAT Medical Enterprise achieves a major milestone: HeadaTerm 2 receives the OTC clearance from the U.S. Food and Drug Administration (FDA),...
the mostfda cleared
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...
laser profda clearedfacemask
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...
epicardial accessfda clearedsafe
https://theradome.com/
Theradome Laser Hair Growth Helmet: FDA-Cleared Hair Device
laser hair growth helmetfda clearedtheradomedevice
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.
blood pressure monitoringfda cleared
https://www.prnewswire.com/news-releases/labcorp-launches-fda-cleared-fentanyl-test-delivering-results-in-10-minutes-302742562.html
Labcorp Launches FDA-Cleared Fentanyl Test Delivering Results in 10 Minutes
/PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the launch of the Labcorp Fentanyl...
fda clearedfentanyl testdelivering resultslabcorplaunches
https://mosiebaby.com/
Mosie Baby: First FDA-Cleared At-Home Syringe Insemination Kit
After struggling to conceive for 2.5 years, Mo and Marc began looking for an easy and comfortable at-home way to do artificial insemination. When they couldn't...
fda clearedat homebabyfirstsyringe
https://identifydiagnostics.com/
Identify Diagnostics | Drug Test Cups FDA Cleared CLIA Waived
Identify Diagnostics USA, and Identify Health drug testing cups provide accurate point of care urinalysis at great prices. 12 panel drug test cups as well as...
drug test cupsfda clearedidentifydiagnosticsclia
https://www.buzzsprout.com/1015072/episodes/18923727
Episode #109| March Newsletter: From Bioprinted Organs To FDA Cleared Implants In Healthcare 3D...
We track the biggest healthcare 3D printing stories from March 2026, from bioprinted organs and sustainable bioinks to FDA-cleared implants and hospital...
https://kffhealthnews.org/morning-breakout/first-breast-cancer-home-screening-dna-test-cleared-by-fda/
First Breast Cancer Home-Screening DNA Test Cleared By FDA - KFF Health News
Mar 7, 2018 - While the FDA cautioned that regular checkups and screenings are still needed, the decision allows people to initiate testing on their own for three genetic...
https://www.keikku.health/
Smart Stethoscope & Al Medical Scribe | Keikku FDA-Cleared
medical scribesmartstethoscopekeikkufda
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.
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...
https://finviz.com/news/341111/natural-cycles-integration-unlocks-fda-cleared-birth-control-app-for-users-with-select-garmin-smartwatches
Natural Cycles integration unlocks FDA-cleared birth control app for users with select Garmin...
Stock screener for investors and traders, financial visualizations.
https://www.healthcaredive.com/news/fda-approve-updated-covid-vaccine-mrna-pfizer-moderna/725076/
Updated COVID shots from Pfizer, Moderna cleared by FDA | Healthcare Dive
The approval of both vaccines, designed to better match the coronavirus strains currently circulating, comes just ahead of the fall and winter seasons.
updatedcovidshotspfizer
https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) | FDA
A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use...
https://www.fiercebiotech.com/medtech/fitbit-tails-apple-watch-fda-cleared-algorithm-passively-check-afib
Fitbit tails Apple Watch with FDA-cleared algorithm to passively check for afib | Fierce Biotech
Apr 11, 2022 - In 2018, Apple irrevocably blurred the line between consumer technology and medical devices as it
https://kffhealthnews.org/morning-breakout/as-push-grows-for-ever-faster-approvals-report-finds-one-third-of-fda-cleared-drugs-posed-safety-risks/
As Push Grows For Ever-Faster Approvals, Report Finds One-Third Of FDA-Cleared Drugs Posed Safety...
May 10, 2017 - Problems with 71 of the 222 drugs approved in the first decade of this millennium were discovered after the drugs were approved, according to a new study....
https://www.sciencenews.org/archive/road-cleared-fda
Road Is Cleared for FDA | Science News
road isclearedfdasciencenews
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...
owlet baby monitor
https://www.philips.com/a-w/about/news/archive/standard/news/press/2026/philips-receives-fda-510k-clearance-for-its-rembra-platform-expanding-access-to-faster-more-precise-ct-imaging-across-frontline-care-and-cancer-treatment-planning.html
Philips Rembra CT platform cleared by FDA | Philips
Philips receives FDA clearance for Rembra platform of scanning systems, including Rembra CT, Rembra RT and Areta RT, expanding access to faster, more precise...
philipsctplatformclearedfda
https://www.biospace.com/sprintray-launches-onx-tough-2-the-first-and-only-3d-printing-resin-fda-cleared-for-fixed-implant-supported-dentures
SprintRay Launches OnX Tough 2, the First and Only 3D Printing Resin FDA Cleared for Fixed,...
Oct 10, 2023 - SprintRay Inc. announced the launch of OnX Tough 2, the first and only 3D printing resin with US Food and Drug Administration 510 clearance for fixed,...
https://www.bustle.com/articles/115221-lime-crime-cleared-by-fda-approved-study-so-shop-these-7-products-safely
Lime Crime Cleared By FDA-Approved Study, So Shop These 7 Products Safely
Oct 7, 2015 - Great news for fans of Velvetines and Unicorn Lipsticks! Lime Crime has been cleared by an FDA-required study, which means you're free to shop highly-pigmented...
https://stockhouse.com/news/press-releases/2025/10/23/labcorp-to-offer-first-fda-cleared-blood-test-to-rule-out-alzheimer-s-related
2025-10-23 | Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid...
(2025-10-23 | NYSE:LH) Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid Pathology in Primary Care Settings
https://www.finanznachrichten.de/nachrichten-2026-03/67891221-dentsply-sirona-first-ever-dental-dedicated-mri-system-validated-in-trial-cleared-by-fda-020.htm
Dentsply Sirona: First-ever Dental Dedicated MRI System Validated In Trial, Cleared By FDA
BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - Dentsply Sirona (XRAY) and Siemens Healthineers (SHL.DE) announced that the dental-dedicated ddMRI system - MAGNETOM...
https://www.livescience.com/health/medicine-drugs/1st-gene-therapies-for-sickle-cell-cleared-by-fda-including-crispr-treatment
1st gene therapies for sickle cell cleared by FDA, including CRISPR treatment | Live Science
Dec 8, 2023 - The FDA approved two new therapies for sickle-cell disease, including the world's first-ever approved CRISPR therapy.
https://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/cleared-510k-submissions-supporting-documents-2024
Cleared 510(k) Submissions with Supporting Documents - 2024 | FDA
List of Cleared 510(k) Submissions with Supporting Documents - 2024
supporting documentsclearedksubmissionsfda
https://www.biospace.com/inspire-r-3d-printed-trabecular-peek-tm-with-hafuse-r-lumbar-interbody-system-cleared-by-fda
Inspire(R) 3D Printed Trabecular PEEK(TM) With HAFUSE(R) Lumbar Interbody System Cleared by FDA -...
Jan 22, 2024 - Curiteva announced FDA 510(k) clearance of the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal,...
https://www.gadgetreview.com/fda-just-cleared-the-first-wireless-brain-implant-for-severe-depression
FDA Just Cleared the First Wireless Brain Implant for Severe Depression - Gadget Review
Brain implant gets FDA clearance for first wireless depression treatment trial, offering battery-free stimulation in 20-minute outpatient procedure.