510 k - Robuta Search

https://orthospinenews.com/2026/03/31/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments/ Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments... receives fda 510 k clearance two additional restore robotics https://diagnostics.roche.com/us/en/news-listing/2026/fda-cobas-c-703-cobas-ise-neo.html Roche receives FDA 510(k) clearance for bcobas/b® c 703 and bcobas/b® ISE neo,... receives fda 510 k clearance roche 703 ise https://www.medtechdive.com/news/pulse-seeks-fda-approval-pfa-clamp/720806/ Pulse drops 510(k) plan for PFA device after FDA requests clinical data | MedTech Dive Analysts said the AFib device is now unlikely to come to market before late 2026. 510 k clinical data medtech dive pulse drops https://www.medtechdive.com/news/fda-starts-510k-pilot-to-cut-optical-tomography-processing-times/540445/ FDA starts 510(k) pilot to cut optical tomography processing times | MedTech Dive The program aims to give developers of optical coherence tomography devices the chance to discuss premarket performance testing recommendations with the agency. 510 k processing times medtech dive fda starts https://www.fda.gov/medical-devices/device-approvals-and-clearances/510k-clearances 510(k) Clearances | FDA Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month. 510 k clearances fda https://www.medtechdive.com/news/mayo-clinic-spinout-510k-heart-failure-screening-a/695281/ Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm | MedTech Dive The algorithm analyzes 12-lead ECGs to show if a patient may be developing heart failure. 510 k clearance mayo clinic heart failure medtech dive partner https://www.hairfacts.com/tips/govregs/fda-510k-intended-use-statements-ndyag-lasers/ FDA 510(k) Intended use statements: Nd:YAG lasers – HairFacts | Hair Removal Information 510(k) intended use statements: Nd:YAG lasers Below is a list of Nd:YAG lasers cleared by FDA. The intended use of each is quoted verbatim from FDA clearances,... fda 510 k hairfacts hair removal intended use statements yag https://innolitics.com/portfolio/fast-510k-breakthrough-ivd/ We Flew Onsite, Read the Code, and Finished the 510(k) Docs in 4 Months 510 k 4 months flew onsite read https://us.cmrsurgical.com/news/cmr-surgical-secures-510k-clearance-of-its-versius-plus-robotic-surgical-system CMR Surgical secures 510(k) clearance of its Versius Plus robotic surgical system - CMR Surgical Dec 17, 2025 - Regulatory clearance of CMR’s most advanced system paves the way for upcoming US commercial launch. 510 k clearance cmr surgical robotic system secures plus https://mesalabs.com/products/renal-care/nist-traceable-combination-solution Calibration Solutions | 510(k), NIST-traceable Solutions | Mesa Labs The Calibration Solution portfolio from Mesa Labs can be used anywhere a meter needs to be calibrated for pH, conductivity, or total dissolved solids. 510 k mesa labs calibration solutions nist https://ridekc.org/routes/510-k10-connector 510 K-10 Connector | Routes | RideKC 510 k connector routes ridekc https://www.medtechdive.com/news/fda-floats-changes-to-special-510k-program/533474/ FDA floats changes to Special 510(k) program | MedTech Dive The update will expand use of the program to a wider range of device modifications. 510 k medtech dive fda floats changes https://www.medtechdive.com/news/FDA-hepatitis-c-testing-reclassification-510k/610416/ FDA shakes up hepatitis C testing market by opening up 510(k) pathway | MedTech Dive Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche. hepatitis c testing market medtech dive fda shakes 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. fda 510 k airs medical oem dl solutions https://atdc.org/us-food-and-drug-administration-gives-huxley-medical-510k-clearance-for-sansa-home-sleep-apnea-test/ Huxley Medical Receives FDA 510(k) | ATDC Member Company Dec 2, 2025 - Huxley Medical earns FDA 510(k) clearance for SANSA, the first chest-worn AI-powered home sleep apnea diagnostic patch improving patient outcomes. receives fda 510 atdc member company huxley medical k https://www.prweb.com/releases/theodent-secures-fda-510k-clearance-for-rennou-varnish-the-first-professional-fluoride-free-cavity-varnish-authorized-in-the-us-302480847.html Theodent secures FDA 510(k) clearance for Rennou® Varnish, the first professional fluoride-free... fda 510 k first professional fluoride free secures clearance https://www.hairfacts.com/tips/govregs/fda-510k-clearance-tweezer-type-epilators/ FDA 510(k) clearance: Tweezer-type epilators – HairFacts | Hair Removal Information FDA 510(k) clearances: Electric tweezers Beginning on 28 May 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate... fda 510 k hairfacts hair removal clearance tweezer type https://www.biospace.com/epitel-receives-fda-510-k-clearance-for-two-new-technologies-remi-remote-eeg-monitoring-system-for-ambulatory-use-and-remi-vigilenz-ai-for-event-detection Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System... Apr 24, 2024 - Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k)... receives fda 510 k clearance two new monitoring system https://www.prweb.com/releases/spinepoint-receives-us-fda-510k-clearance-for-flex-z-cervical-cage-first-product-in-the-ultra-low-stiffness-cushioning-interbody-platform-302725995.html SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage/ First Product in the... Mar 27, 2026 - /PRNewswire-PRWeb/ -- SpinePoint LLC, a medical device company developing low stiffness cushioning spinal interbody cages through advanced additive... fda 510 k receives u cage first clearance flex