FDA 510(k) clearances — page 20
clearances on record, most recent first.
Clearances — page 20
1,901–2,000 of 176,479- K260647 — SPECCHIO
- K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat
- K242303 — MOD-C
- K252513 — Polywin Safety (14G x 51mm +17 more
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
- K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- K253405 — Prana System
- K253473 — Synchrony
- K253582 — Medical Imaging Calibration Feature (MICF)
- K253586 — RM Electrode (RMH 25-01)
- K253718 — enHAnce PEEK Bunion System
- K254015 — CoLumbo C-Spine
- K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
- K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
- K260276 — Arm Blood Pressure Monitor Models: ARM-30C+ +26 more
- K253029 — RW-1
- K253598 — InjecSURE Injection System
- K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
- K260191 — Safety lancet (XXXVII)
- K260319 — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- K260375 — Nd: YAG Laser Therapy Systems
- K252158 — Sagami Original 002 Polyurethane Male Condom
- K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
- K252269 — FINDER Flu A&B/SARS-CoV-2 Test
- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K253950 — Avatar Medical Vision
- K254122 — FLOW FLEXTEND Wand (72290039)
- K254207 — AiORTA - Plan v2.0
- K260037 — implantcast Packaging System Update
- K260370 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K260812 — Francisella tularensis Real-time PCR Assay
- K252360 — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- K260257 — CO2 Laser System
- K251273 — Asurys Fluid Management System
- K252006 — OTTO Disinfecting Cap
- K252064 — MedCAD® AccuStride System
- K252081 — SportLinc Syndesmosis Device
- K252148 — Butterfly Gestational Age Tool
- K252195 — ARTICOR planner
- K252295 — Ryurei
- K252893 — ExaStim® Stimulation System (EXA-001) +3 more
- K253270 — Contour ProtégéAI+
- K253307 — Electric wheelchair
- K253392 — Synergy Disc Instruments
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K253649 — Spectral CT Verida Family
- K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- K253980 — Electrically Powered Wheelchair (Model YC-01)
- K254099 — EVO Q30 Diagnostic Ultrasound System +8 more
- K254161 — Automated Aortic Stenosis Software (AutoAS)
- K254206 — Power wheelchair (ZS-EW8026)
- K254239 — CyClean Cord
- K260041 — MDx-Chex for BCP
- K260240 — SYMPHONY Navigation Ready Instruments
- K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
- K260294 — SF Push-in Anchor
- K260697 — VyPlate Anterior Cervical Plate System
- K260746 — S-scan Open (100001800)
- K252926 — Robotic Surgical Instruments - Permanent Cautery Hook (470183) +1 more
- K253379 — Stealth AXiS Cranial clinical application
- K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555)
- K253627 — Surgify Halo (11 models)
- K253775 — SwiftMR
- K253796 — Lunit INSIGHT DBT (V1.2)
- K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
- K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- K260601 — REAL INTELLIGENCE CORI
- K260626 — Multiflex Steerable Sheath 17.5F
- K252023 — MiraChlor Antimicrobial Wound Solution
- K252037 — CUVIS-joint (CJ150)
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K252432 — Flex-Z Cervical Cage
- K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- K253615 — Invictus Bands System
- K253680 — LYNX COBLATION Laryngeal Wand (72290254)
- K254278 — Arterial Pressure Monitoring Set/Tray
- K260274 — Airlock® Ankle Plating System
- K260291 — Vortex5 Tailor's Bunion Correction System
- K252099 — Trinias
- K252169 — Access BNP II
- K252421 — JLK-NCCT
- K253047 — PRESSONE
- K253198 — NanoKnife Generator (H78720300351US0)
- K254012 — Electric Wheelchair (E201)
- K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5
- K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- K260673 — LOGIQ Vita +9 more
- K260787 — FebriDx Bacterial/Non-bacterial Assay
- K252031 — Adin Long Dental Implant System
- K252992 — CT Rembra RT; CT Areta RT
- K253686 — True Definition DL
- K254166 — MDx-Chex for BCN
- K254275 — HyperSuture All Green Extension Line
- K254288 — Clavicle Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.