FDA 510(k) clearances — page 261
clearances on record, most recent first.
Clearances — page 261
26,001–26,100 of 175,699- 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
- K173887 — cobas CT/NG for use on cobas 6800/8800 systems
- K180023 — WIRION
- K180148 — ATS Thermal Imaging Probe, ATS Patient Interface Unit
- K180192 — Emprint Ablation Visualization Application
- K180211 — Freezpoint
- K180274 — Ventix Link Knotless Anchor with Inserter
- K170957 — ReConnex Pre-Sutured Tendon
- K171989 — Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
- K172762 — Single Use Hemoclip
- K173451 — Ingenia Elition S and Ingenia Elition X
- K173919 — HX Device
- K180015 — Philips Incisive CT
- K180016 — Home Use IPL Beauty Device
- K180165 — Habib EndoHPB
- K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- DEN170029 — PrimeStore MTM
- K171863 — Anjon Bremer Halo System
- K171912 — Double Flexible Tip Wire Guides
- K172148 — Anchorage Bone Plating System
- K172264 — OTW Takeru PTCA Balloon Dilatation Catheter
- K173237 — Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
- K173437 — 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
- K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K173740 — Reprocessed DePuy Mitek Ablation Wand
- K173930 — PYTHON Plate Trial Instruments
- K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System
- K180579 — Ezee Retrieval
- K173841 — AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
- K171542 — TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
- K171851 — SOFTXIL
- K171937 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K172366 — Wrist Pulse Oximeter
- K172516 — SurgiQuest AIRSEAL iFS System
- K172593 — XCelliStem Wound Powder
- K172928 — Portable X-ray System
- K173120 — CCM Abutment System
- K173181 — ExSpiron 1Xi
- K173326 — MIS CONNECT Conical Connection Abutment
- K173358 — ARTAS System
- K173611 — syngo Application Software
- K173752 — SI Screw System
- K173840 — Xpert CT/NG
Data sourced from openFDA. This site is unofficial and independent of the FDA.