FDA 510(k) clearances — page 260
clearances on record, most recent first.
Clearances — page 260
25,901–26,000 of 175,699- K171713 — Neodent Instrument Kits
- K171847 — Corin Optimized Positioning System (OPS) Plan
- K172014 — Wedge Microcatheter
- K172156 — PENTAX Medical EPK-3000 Video Imaging System
- K172368 — Bipolar Micro-Coagulation Forceps
- K172998 — uWS-MI
- K173207 — SIC invent Dental Implant Systems
- K173333 — GORE ENFORM Biomaterial
- K173526 — SENTIO MMG Gen 2
- K173586 — VAMP Venous/Arterial Blood Management Protection System
- K173867 — Axis Anterior Cervical Plate System
- K173897 — syngo.via MI Workflows
- K180089 — Medacta Shoulder System Short Humeral Diaphysis
- K180125 — PowerLook Density Assessment Software
- K180344 — TheraCal DC
- K180349 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K180376 — K2M Patient Specific Rods
- K180378 — Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
- K180589 — DR 800 with MUSICA Dynamic
- K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K172141 — Pulse Oximeter
- K172239 — SIMPLANT 18
- K172963 — Master-Frank N95 Particulate Respirator
- K173072 — Algidex Ag Silver Alginate Wound Dressing
- K173074 — ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
- K173079 — Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
- K173597 — Scenium VE20 Software
- K173699 — The Pump by Babyation
- K180088 — TrapLiner catheter
- K180339 — Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
- K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K180561 — MobileX Portable X-ray System
- K180571 — GammaPod
- K180595 — SciMoCa
- K180637 — leva Pelvic Floor Trainer
- DEN170047 — Curetis Unyvero LRT Application
- K172630 — Kisses Plus Implant System
- K172635 — High-Flo Silver Polyethylene Catheter
- K173362 — DSM Biomedical Calcium Phosphate Cement
- K173506 — LigaPASS
- K173885 — Genesys Spine Binary Lumbar Plate System
- K173958 — OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
- K180243 — Infinity-Lock Button System
- K180320 — dpl IIa Panel
- K180503 — PRECICE STRYDE System
- K180566 — Unite Connect for Clinical Systems
- K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
- K180677 — Surefire Spark Infusion System
- K171692 — Instrument basket, for EndoEYE
- K172382 — GC Fuji Direct
- K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
- K173669 — K-D Balance
- K173896 — Microcyn Antimicrobial Hydrogel
- K180210 — CREO® Stabilization System
- K180586 — Varian Head Frame
- K170608 — UF(II) Implant System
- K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip
- K171867 — Drs Finder NEO
- K171952 — Dimesol Tubing Sets for Hemodialysis
- K171988 — Performer Guiding Sheath
- K171997 — Mandril Wire Guide
- K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA
- K172246 — OLYMPUS URF-V2/V2R
- K172312 — eego amplifiers
- K172335 — Bleep DreamPort
- K173029 — Nipro Syringe
- K173379 — Straumann Variobase for Crown AS
- K173517 — RADspeed fit
- K173548 — Merit Pursue Microcatheter
- K173617 — MAGNETOM Vida with Compressed Sensing GRASP-VIBE
- K173630 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
- K173637 — syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
- K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
- K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
- K180323 — Vitrea Software Package; VSTP-001A
- K180538 — gammaCore Sapphire
- K180592 — G-scan Brio
- K171624 — IXOS Radius Plate System
- K171841 — Arthrex Shoulder System
- K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
- K172298 — OLYMPUS URF-P6/P6R
- K172322 — Atellica IM Total hCG (ThCG)
- K172843 — TwitchView System
- K173057 — Zimmer Knee Joint Replacement Prostheses MR Labeling
- K173082 — Arco-SA Lumbar Cage System
- K173439 — Bloom2 Programmable Electrophysiology Stimulator
- K173533 — Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
- K173799 — NaviCross 0.018
- K180517 — CorPath GRX System
- K180531 — NovoStitch Pro Meniscal Repair System
- K180535 — Voluson P6 and Voluson P8
- K171969 — Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
- K172235 — CoreHip® System
- K172444 — ROSA BRAIN (v3.0.0.5)
- K172627 — David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
- K173465 — Concentrix MX-AC High-Speed Handpiece
- K173489 — GYN-Pump PH304
- K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
- K173727 — Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
- K180056 — Genesys Spine AIS-C Cervical Anchored Interbody System
Data sourced from openFDA. This site is unofficial and independent of the FDA.