FDA 510(k) clearances — page 55
clearances on record, most recent first.
Clearances — page 55
5,401–5,500 of 176,479- 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) +6 more
- 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 +2 more
- 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) +2 more
- K241587 — pilot TLS
- K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves
- K243918 — Vasoview Hemopro 3 Power Supply
- K244031 — Disposable Blood Lancet (4 models)
- 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) +8 more
- K243446 — 3DXR
- K250223 — BruxZir® Esthetic NOW
- K250238 — WasherCap Fixation System
- K250348 — JLK-AILink
- K241565 — Sterilization Package/Reel
- K241703 — SD Implant System
- K242994 — OncoStudio (OS-01)
- K243035 — Ulthera® System
- K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing
- K243823 — Control-IQ+ technology
- K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- K244010 — ExamVue Apex
- K241186 — Synthetic Bone Graft Particulate
- K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
- K241563 — Extremity Medical External Fixation System
- K241983 — Fassier-Duval Telescoping IM System
- K242607 — ScanDiags Ortho L-Spine MR-Q
- K242838 — QuickRad
- K242850 — Wearable breast pump (model W8)
- K242898 — Sterilization Pouches and Reels
- K243088 — Green X 12 SE (PHT-40CHS)
- K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
- K243258 — Paradigm System
- K243278 — Custom Abutments
- K243330 — LYMA Laser PRO
- K243431 — Medicom Sterilization Pouch and Reel
- K243614 — Sonio Suspect
- K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
- K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
- K243916 — Primus Spinal Fixation System
- K243940 — VITA YZ Multi Translucent
- K243951 — TEMP MASTER, PMMA-based dental resin
- K250027 — Powered Mobility Scooter
- K250218 — Xpert® FII & FV
- K234004 — Medical diode laser systems (CHARISMA, REGAL)
- K241470 — CORE Shoulder System
- K241626 — SperSort Sperm Sorting Chip (IPG02)
- K242240 — CaRi-Plaque
- K242447 — Falcon HST
- K242681 — NUSONO Handheld Ultrasound Scanner (3 models)
- K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
- K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91) +1 more
- K243283 — Alinity h-series System
- K243312 — CER-S
Data sourced from openFDA. This site is unofficial and independent of the FDA.