Recent Clearances – Updated as of March 28, 2025
Joylux, Inc | Joylux Intimacy Gel (PG3100)
Device Classification Name: Lubricant, Personal
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242958
Ormco Corporation | SparkTM Clear Aligner System
Device Classification Name: Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250487
Edan Instruments Inc. | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250214
Huntleigh Healthcare Ltd. | Sonicaid Team3
Device Classification Name: System, Monitoring, Perinatal
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241368
ICU Medical, Inc. | Rio™ Drug Reconstitution Transfer Device
Device Classification Name: Set, I.V. Fluid Transfer
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243985
Unity Medical, Inc. | VersaD Delivery Catheter
Device Classification Name: Catheter, Percutaneous, Neurovasculature
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242051
Erchonia Corporation | Erchonia Zerona® VZ8
Device Classification Name: Fat Reducing Low Level Laser
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243811
Ormco Corporation | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
Device Classification Name: Adhesive, Bracket And Tooth Conditioner, Resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250015
Handpiece Headquarters | HPR Cordless Hygiene Handpiece
Device Classification Name: Handpiece, Direct Drive, Ac-Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243911
AI Optics | Sentinel Camera
Device Classification Name: Camera, Ophthalmic, Ac-Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243664
Verily Life Sciences, LLC | Verily Numetric Retinal Camera
Device Classification Name: Camera, Ophthalmic, Ac-Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242508
Yukon Medical, LLC | SmartSiteTM Vented Vial Access Device
Device Classification Name: Set, I.V. Fluid Transfer
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243486
XF Agencija Limited | Nooro Body & Foot Stimulator (SM9141, SM9142)
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243334
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Natus BrainWatch System
Device Classification Name: Reduced- Montage Standard Electroencephalograph
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242930
Siemens Medical Solutions USA, Inc. | ACUSON Redwood Diagnostic Ultrasound System
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243299
Pollogen Ltd. | Legend X Desktop System
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243217
Devicor Medical Products, Inc. | Mammotome AutoCore™ Single Insertion Core Biopsy System
Device Classification Name: Instrument, Biopsy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243095
NordicNeurolab AS | nordicMEDiVA
Device Classification Name: System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243209
Medical Graphics Corporation | Ascent Cardiorespiratory Diagnostic Software
Device Classification Name: Calculator, Predicted Values, Pulmonary Function
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242809
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. | Safe Secure Sterilization Pouches and Rolls
Device Classification Name: Wrap, Sterilization
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242839
Vave Health, Inc | Vave Wireless Ultrasound System
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241051
Natus Manufacturing Limited | Grass® MR Conditional/CT Cup Electrodes
Device Classification Name: Electrode, Cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242346
Solta Medical | Fraxel® FTX Laser System
Device Classification Name: Powered Laser Surgical Instrument
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242142
Mectron S.p.A. | MT-Bone
Device Classification Name: Drill, Bone, Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242432
Siemens Medical Solutions, USA, Inc. | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240704
NordicNeuroLab AS | nordicMEDiVA
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241608
Plexus Yoga LLC Dba Chirp | TENS&EMS units (SM9109A, SM9109B)
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241509
Bios S.R.L. | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Device Classification Name: powered laser surgical instrument
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241407
eResearchTechnology GmbH | SpiroSphere, SpiroSphereECG, CardioSphere
Device Classification Name: calculator, predicted values, pulmonary function
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223629
Anqing Pukang Medical Technology Co., LTD. | Disposable Vinyl Examination Gloves
Device Classification Name: vinyl patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241252
Pollogen Ltd. | Legend X Applicator VO
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240999
Atraverse Medical | HOTWIRE™ RF Guidewire
Device Classification Name: catheter, septostomy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240900
Philips Medical Systems Technologies | Image Management V15
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240822
Infinite Biomedical Technology LLC | Glide (91000-GL-X)
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240884
Alembic, LLC | APRO 55 Catheter
Device Classification Name: catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234115
Kids-e-Dental LLP | e-SDF
Device Classification Name: diammine silver fluoride dental hypersensitivity varnish
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240619
SPM Medicare Pvt. Ltd. | Insulin Syringe
Device Classification Name: syringe, piston
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233794
Deerfield Imaging, Inc. | InVision™ 1.5 Surgical Theatre
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240157
Gelb Practice Solutions, Inc. | airVata™
Device Classification Name: device, anti-snoring
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240427
Deerfield Imaging, Inc. | InVision™ 1.5 Surgical Theatre
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240157
TriSalus Life Sciences | TriSalus TriGuideTM Guiding Catheter
Device Classification Name: catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233858
3M Unitek Orthodontic Products | 3M™ Transbond™ Orthodontic Adhesive
Device Classification Name: adhesive, bracket and tooth conditioner, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234043
Siemens Healthcare GmbH | syngo Virtual Cockpit (VB10A)
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232744
Acutus Medical, Inc. | FlexCath Cross Transseptal Solution
Device Classification Name: introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233691
BB Imaging | TeleScan
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233634
FUJIFILM SonoSite Inc. | Sonosite LX Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233597
Philips Ultrasound LLC | EPIQ Series Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233545
Micro Current Technology, Inc. | MF SC Facial Toning System
Device Classification Name: stimulator, transcutaneous electrical, aesthetic purposes
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233525
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | VarseoSmile TriniQ
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233596
Guangzhou Easycess Medical Co., Ltd | Easycess Aspiration Pump
Device Classification Name: apparatus, suction, ward use, portable, ac-powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233428
Handpiece Headquarters | BASE290 LED Curing Light
Device Classification Name: activator, ultraviolet, for polymerization
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233518
GuideStar Medical Devices | EpiZact
Device Classification Name: syringe, piston
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233056
Pollogen Ltd | Legend X Platform
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232903
Cross Vascular Inc. | Cross Vascular RF Generator and Footswitch (optional accessory)
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232809
Cross Vascular Inc. | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Device Classification Name: catheter, septostomy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232852
Synaptive Medical Inc. | Synq Software Version 1.3
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232981
Invivo Corporation (Business Trade Name: Philips) | dS Breast Coil 7ch 1.5T
Device Classification Name: coil, magnetic resonance, specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232762
3M Company, Unitek Orthodontic Products | 3M™ Clarity™Aligners with Quick Attachments
Device Classification Name: aligner, sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233257
Shofu Dental Corporation | BeautiLink SA
Device Classification Name: cement, dental
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233161
Siemens Medical Solutions, USA, Inc | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232617
Sino-Dentex Co., Ltd. | DX. Bond V Dental Bonding Adhesive
Device Classification Name: agent, tooth bonding, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232978
Passy-Muir, Inc. | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Device Classification Name: filter, bacterial, breathing-circuit
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230483
LightForce Orthodontics | LightForce Orthodontic System
Device Classification Name: bracket, ceramic, orthodontic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232827
Zirkonzahn Srl | Polibond
Device Classification Name: resin, denture, relining, repairing, rebasing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232691
Sleepiz AG | Sleepiz One+
Device Classification Name: monitor, cardiac (incl. cardiotachometer & rate alarm)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223163
Altris, Inc. | Altris IMS
Device Classification Name: system, image management, ophthalmic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232088
US Glove Supply | MemorialTM Gloves
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231740
Bemer INT AG | Bemer Therapy System Evo
Device Classification Name: stimulator, muscle, powered, for muscle conditioning
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231368
DICOM Grid dba Ambra Health | Ambra PACS
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231360
3M Company, Unitek Orthodontic Products | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
Device Classification Name: aligner, sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231464
Mectron S.p.A. | Combi Touch
Device Classification Name: scaler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231391
Philips Ultrasound LLC | EPIQ Series Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231190
3M ESPE Dental Products | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Device Classification Name: varnish, cavity
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231338
TriSalus Life Sciences | TriSalus TriNav® LV Infusion System
Device Classification Name: catheter, continuous flush
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230957
Chongqing Rob Linka Science And Technology Co., Ltd. | TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230829
Alliage S/A Industrias Medica Odontológico. | Eagle S/Saevo Slim/D700 Slim
Device Classification Name: system, x-ray, extraoral source, digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230732
Sprig Oral Health Technologies, Inc. | SmartMTA Capsule
Device Classification Name: resin, root canal filling
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230797
CyMedica Orthopedics, Inc. | Motive™ Electrode
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230533
Siemens Healthcare GmBH | Syngo Carbon Space VA30A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230561
ALG Health LLC | Savvy Surgical Mask – Level 3
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230383
Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230207
Siemens Healthcare GmBH | syngo.via View&GO VA40A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230196
