FDA 510(k) clearances — page 269
clearances on record, most recent first.
Clearances — page 269
26,801–26,900 of 176,542- 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 +3 more
- K180056 — Genesys Spine AIS-C Cervical Anchored Interbody System
- K180504 — Mission Lipid Panel Monitoring System
- K180558 — PressureWire X
- DEN170088 — Dexcom G6 Continuous Glucose Monitoring System
- K170605 — Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
- K171241 — Pulse Oximeter
- K171966 — Mpact® 3D Metal Implants and Augments 3D Metal
- K172269 — FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
- K173214 — NES Reprocessed RF Stylet (RFS)
- K173660 — LenSx Laser System
- K180063 — OCM-G1 Attachment
- K180114 — AEON Retrieval Bag
- K180308 — Prelude
- K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
- K180537 — Zavation Buttress Plate System
- DEN170023 — ThermoNeuroModulation Device, TNM Device
- K172017 — Black Silicone Filiform Double Pigtail Stent Set
- K172354 — OssBuilder System
- K172760 — REST EAZY Appliance
- K173310 — SmartTouch
- K173922 — C-PTFETM Surgical Suture
- K180149 — Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
- K180315 — DISKOM
- K172035 — EKOS ultrasound EVD Device, EVD Control Unit
- K170410 — Longeviti PMMA Static Cranial Implant
- K170753 — Acculoc Total Knee System
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K172496 — SUPERCATH 5 (26G)
- K172648 — Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
- K172723 — Dario LC Blood Glucose Monitoring System
- K173241 — MED-TAB
- K173425 — SRT-100+
- K173886 — CPRmeter 2 CPR Feedback Device
- K180052 — UriSwab-Urine Collection, Transport and Preservation System
- K180473 — ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
- K172371 — Arthrex UNIVERS REVERS COATED BASEPLATE
- K173105 — Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
- K173128 — Alamo® C
- K173134 — SENTIO MMG Pedicle Access Needles
- K173760 — Monarch Endoscopy Platform (Monarch Platform)
- K173903 — Granada Medium
- K173915 — Test of Variables of Attention (T.O.V.A.)
- K180074 — Diazyme Lipoprotein (a) Assay
- K180431 — Cortina [MAX] Lumbar Cage System
- K180443 — Tumark Vision
- K180453 — Bio-Medicus Adult Cannulae and Introducer
- K180456 — Bio-Medicus Adult Cannulae Kit
- K180486 — HemosIL Factor XII Deficient Plasma
- K163661 — P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
- K171973 — Captura® Disposable Hot Biopsy Forceps
- K171982 — DROPLET PEN NEEDLE
- K172168 — WillCeph
- K172611 — Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
- K173408 — Mammomat Revelation
- K173571 — Element System with IBT Electrodes
- K173607 — SOMATOM Edge Plus
- K173619 — Mimics inPrint
- K173846 — DermaScalp Laser Cap
Data sourced from openFDA. This site is unofficial and independent of the FDA.