FDA 510(k) clearances — page 241
clearances on record, most recent first.
Clearances — page 241
24,001–24,100 of 175,699- K181443 — Accula RSV Test
- K182304 — Hyper GP (tisilfocon A) Daily Wear Contact Lens
- K182684 — HammerTechTM Fixation System
- K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
- K182967 — Visor System
- K182306 — Sunkingdom Slit Lamp
- K173744 — ProFuse CAD
- K180541 — DePuy Synthes 2.0 mm Quick Insertion Screws
- K180546 — Jet Power Injectable PICC
- K181123 — ApnoDent Appliance
- K181297 — DENTIOIII series (DENTIOIII, DENTIOIII-S)
- K181454 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
- K181704 — Transpara
- K181996 — MATRx Plus
- K182027 — Wet Organics Personal Lubricant
- K182277 — Versana Premier
- K182352 — SP-LINK System
- K182581 — PlayMakar Sport Muscle Stimulator, Model PRO-500
- K182606 — PINPOINT Endoscopic Fluorescence Imaging System
- K182779 — ARK EDDP Assay
- K182909 — Roth Net Retriever Product Line
- K182957 — Heli-FX EndoAnchor System
- K182977 — Isolette 8000 Plus
- K180550 — NuVasive Monolith Cervical Corpectomy System
- K180917 — GC Acrylic Primer
- K181247 — Vitrea CT Brain Perfusion
- K181731 — MR Compatible Aspiration Kit
- K181806 — ARIX Sternal System
- K181857 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K182133 — Infrared Thermometer
- K182265 — CodMan Certas Plus Programmable Valve
- K182274 — Orbit Subretinal Delivery System
- K182288 — TPH Spectra ST Flowable Composite Restorative
- K182291 — 6MP Color LCD Monitor (C61W+)
- K182652 — COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
- K182696 — Telepack X LED
- K182715 — Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
- K182931 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
- DEN180030 — QMS Plazomicin Immunoassay
- K180432 — AI-ECG Platform
- K182535 — R3 Anteverted Liners
- K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- K182772 — Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil
- K173373 — SafeT T-Piece Resuscitator
- K180184 — Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
- K180343 — LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
- K180528 — InstruSafe(R) Sterilization Container
- K180645 — Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
- K180881 — HemoSphere Advanced Monitor, HemoSphere Pressure Cable
- K180979 — PureFlex Arterial Cannulae
- K181137 — IT-III active System
- K181140 — Axis Chena Cervical PEEK Spacer System
- K181396 — Oral Device OA, Oral Device S
- K181643 — SmartBag (SmartPouch)
- K181646 — Celesteion, PCA-9000A/3, V6.5
- K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor
- K181921 — Solidity Vertebral Body Replacement
- K181948 — 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
- K182090 — AposTherapy System
- K182109 — REDAPT Modular Acetabular Shell
- K182179 — AdvantageRib Anterior System
- K182201 — Stratum Foot Plating System
- K182298 — hemochroma PLUS System
- K182562 — Hair Boom 69
- K182626 — OEC One
- K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
- K182958 — 1.5T 16ch Breast Coil
- K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
- K173971 — K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
- K180650 — Amsel Endo Occluder
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
- K181292 — PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
- K181324 — FilmArray Pneumonia Panel plus
- K181689 — Nexcomp
- K181750 — SITZMARKS
- K181831 — IntelliVue Multi-Measurement Module MMX
- K181897 — Reprocessed Marinr Diagnostic EP Catheter
- K181985 — Voluson E6, Voluson E8, Voluson E10
- K181998 — CardioBand ECG Event Recorder
- K182182 — YUKON OCT Spinal System
- K182255 — CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
- K182528 — Nitrile Glove Powder Free Black
- K183117 — PathLoc-L MIS Spinal System
- K172602 — Miracu
- K180463 — Apoller Flow Light Cure Flowable Composite
- K181090 — Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
- K181434 — SporView Rapid Read Biological Indicator SteamPlus Test Pack
- K181497 — HPM-6000UF
- K181829 — Velofix TLIF Cage
- K181850 — Inversa Implants
- K181886 — VivaSight-DL System
- K181963 — ostaPek Interbody Fusion Cages
- K182097 — React 71 Catheter
- K182101 — Riptide Aspiration System (React 71 Catheter)
- K182105 — JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant
- K182543 — Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
- K182603 — Z6 Diagnostic Ultrasound System
- K182604 — New Era
- K182653 — Voyant Maryland Fusion Device
- K182882 — CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
Data sourced from openFDA. This site is unofficial and independent of the FDA.