FDA 510(k) clearances
clearances on record, most recent first.
Most recent clearances
1–100 of 175,572- K253480 — Capenergy C Equipments RF C200 and C400 Drakarian
- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
- K253670 — SmartCT (R3.0 (L10))
- K254037 — LungFlow Airway Catheter
- K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- K260880 — SedLine Sedation Monitor
- K260902 — Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System
- K261031 — POSEIDON ST
- K261041 — ClearSafe Closed System
- K261149 — Electric Wheelchair (DY611A-2, DY612A-1)
- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K261306 — AI Contouring (VA10A)
- K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
- K262120 — Avara Viewer
- K252978 — ScioCardio ECG Analysis Platform
- K253899 — 3D-Anywhere
- K253901 — Millipede88 Access Catheter
- K260157 — LifeLens Physiological Monitor
- K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter
- K260723 — HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)
- K261166 — DIA-CEM
- K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer
- K261471 — Zeta TMS Navigation System
- K261569 — UbiqVue 2AYe Cardiac System (UX2253)
- K261962 — SmartGuard Technology; Predictive Low Glucose Technology
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
- K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
- K253751 — CXRDetectAI
- K254130 — C.A. Medical Interbody Fusion System
- K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K260278 — ThermAffyx(TM) Patient Safety System
- K260700 — BlueDop Vascular Expert
- K260750 — Virtual Cone (1.0)
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K261191 — Alians Elbow S
- K261396 — Electric Wheelchair
- K262300 — Denture Base Resin V2
- K253942 — Pulmonex II Xenon System (132-503)
- K260973 — InferOperate Suite
- K261163 — Mobility Scooter (R200)
- K261164 — Electric wheelchair (XW-LY007 )
- K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
- K262045 — Luja Soft
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K253317 — Cytrans Elashield
- K260122 — Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
- K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)
- K261465 — INDIRA CLOUD VIEWER
- K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
- K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories
- DEN250034 — Claria System
- K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit
- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K253463 — ILR ECG Analyzer (IM007)
- K253704 — iPredict-DR
- K253884 — Koios DS (3.8)
- K260527 — FACE4D Aligner
- K260528 — OncoStudio
- K260596 — Collagen Wound Powder
- K260755 — OptraSCAN System
- K261129 — OrthoFit
- K261587 — Insufflation Retention Device (IRD) (11173-325-101)
- K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
- K261847 — iTero Lumina Pro
- K261867 — Xpert Carba-R
- K261880 — FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
- K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
- K252483 — Enteral Syringe (20ml, 60ml)
- K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy
- K253434 — OSSTM Orthopedic Salvage System
- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
- K260556 — Veritas Shoulder System
- K261021 — EasyWhip Family
- K261054 — RibPlate System
- K261147 — Neodent Implant System - NeoConvert Fit
- K261473 — Chromix
- K261474 — DENTCA Tru Flexible
- K261485 — Tetric plus Fill;Tetric plus Flow
- K261852 — OTS Hip
- K261889 — Trevo Trak 21 Microcatheter
- K262228 — Transcend Bulk Fill Flowable Composite
- K253767 — UB ERP System
- K260576 — MeVis AVM Contour
- K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- K261101 — Ceribell Monitor
- K261119 — NorthStar Mapping System (MAP01 or MAP01-01)
- K261808 — ISAAC Neurovascular Navigation Catheter
- K262195 — Dandy Ceramic Stain and Glaze
- K251492 — Irrigation Tubing Bipolar Cord Set
- K253484 — LUTRONIC GENIUS
- K253628 — Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
- K253969 — ADAS 3D
- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
- K260667 — Alturion Series Diagnostic Ultrasound System
- K260918 — Zolid Lunaris
- K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
Data sourced from openFDA. This site is unofficial and independent of the FDA.