FDA 510(k) clearances — page 46
clearances on record, most recent first.
Clearances — page 46
4,501–4,600 of 175,620- K243839 — Alteon® HA Femoral Stems
- K250188 — Wound Treatment System (VHT-200)
- K241159 — Handbike Batec Electric
- K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
- K242207 — NOABLE LASER
- K242338 — Cleerly LABS (v2.0)
- K242383 — Apex Locator
- K242510 — Geistlich Bio-Flow®
- K242642 — CuffTrek
- K242890 — SPINEART Navigation Instrument System
- K242914 — Op.n(TM) Navigation
- K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom
- K243515 — EpiWatch Monitoring System
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon
- K243798 — Orthex External Fixation System
- K243801 — FRONT-LINE Field Sterilizer (FL135)
- K243970 — Portable Wheelchair
- K241767 — Versacem Acetabular Shell and Double Mobility HC Liners
- K241790 — XCELLARISPRO TWIST microneedling device
- K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP
- K243331 — LVivo Seamless
- K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant
- K243587 — PureLift GLOW
- K243724 — Persona® Revision Knee System (Persona Revision SoluTion Femoral Components)
- K243842 — Intra-Operative Positioning System (IOPS®)
- K243871 — Philips IntelliSite Pathology Solution 5.1
- K250344 — BD Phoenix Automated Microbiology System
- K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K241770 — Prostate MR AI (VA10A)
- K242149 — NovoSorb® MTX
- K242190 — Access Cortisol; DxC 500i Clinical Analyzer
- K242597 — CROSSLEAD 0.018inch
- K243751 — Mako Total Hip Application 5.0
- K250304 — TITANEX Screw Systems
- K232383 — iPhysio® System
- K241679 — Disposable Cytology Brush (AF series)
- K243461 — Calibrate Interbody Systems
- K243809 — Biolox® Delta Revision heads
- K243933 — Ceevra Reveal 3+
- K241947 — EnergyLounger (TY-01)
- K242943 — Q Switched Nd:YAG Laser machine (QNHF-01)
- K243235 — LVivo Software Application
- K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
- K243611 — JLK-SDH
- K243881 — HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
- K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400)
- K241041 — Silver Fluoride Hypersensitivity Varnish
- K241374 — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
- K241617 — Durex Polyisoprene Condom
- K241717 — E1000 Dx Digital Pathology Solution
- K241922 — Myomics
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
- K242339 — Intravascular Extension Sets and Accessories
- K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
- K242718 — Portable Oxygen Concentrator (P2-TOC)
- K242798 — Airmod
- K242876 — Pulse Oximeter ( PO2, PO2A, PO2B)
- K243359 — MagDI System (MAG-02, DS-01)
- K243436 — Seclusion Catheter
- K243565 — DYNAMIS SI Screw System
- K243582 — da Vinci SP Advanced Access Port Kit (432701)
- K243730 — Xpert C. difficile/Epi
- K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
- K244039 — MedalOne Total Knee System
- K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
- K250324 — QIAstat-Dx GI Panel 2 Mini B
- K241550 — Gelweave Vascular Prostheses
- K241586 — PIVO Pro Needle-free Blood Collection Device
- K241595 — EzVu Visual Vasopressor injector (EV-19)
- K241620 — ChestView US
- K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
- K242175 — XOD Diathermia Radiofrequency Device
- K242900 — VADER® Pedicle System and VADER®one Pedicle System
- K243357 — CastleLoc Pectus Bar System
- K243543 — microINR System
- K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
- K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
- K250021 — Rotium
- K241222 — Ventripoint Medical System Plus (VMS+) 4.0
- K241546 — aiCockpit AI Viewer
- K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
- K241587 — pilot TLS
- K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves
- K243918 — Vasoview Hemopro 3 Power Supply
- K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
- K244036 — Heel Incision Safety Lancet (SteriHeel 2)
- K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- K250202 — Aventus Thrombectomy System
- K250281 — DEKA LOTUS
- K250346 — BonVie+
- K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
- K241601 — EMS (FlexPulse, MagnaCore, Magnetika)
- K242822 — ART-Plan+ (v.3.0.0)
- K242967 — Loss of Pulse Detection
- K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
- K243446 — 3DXR
- K250223 — BruxZir® Esthetic NOW
- K250238 — WasherCap Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.