FDA 510(k) clearances — page 249
clearances on record, most recent first.
Clearances — page 249
24,801–24,900 of 176,542- K181667 — Thoraguard System
- K181816 — Ceramic Denture Zirconia Ceramics Block
- K181880 — VivaSight-SL (TVT) system
- K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
- K182181 — Persyst 14 EEG Review and Analysis Software
- K182418 — V3 Segmental Plating System
- K182587 — Device Electrosurgical Generator ESG-150
- K182757 — Espire Elbow Pro, Espire Elbow Hybrid
- K182988 — Afinion HbA1c Dx on Afinion 2
- K180207 — Non-contact Infrared Thermometer
- K180498 — NuVasive Reline Fenestrated Screws, High V+ Bone Cement
- K180665 — SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
- K181604 — Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
- K181693 — SMS Femoral Stem
- K182380 — AEON Endoscopic Stapler
- K182992 — BGM014 Blood Glucose Monitoring System
- K183010 — Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
- K182169 — AdVance XP Male Sling
- K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
- K182369 — gammaCore Sapphire
- K182746 — ATEC ALIF and LLIF Spacer System
- K182764 — Biop Digital Colposcope
- K182801 — Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
- K182983 — iFuse Implant System®
- K172837 — Low-frequency Multi-function physiotherapy instrument
- K181112 — Orchestrate 3D
- K182134 — ARiX RAD Radiographic System
- K182324 — EkoSonic Endovascular System
- K182346 — TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
- K182431 — Konicaminolta DI-X1
- K182470 — Plateau Spacer System
- K182699 — Selethru PTCA Balloon Dilatation Catheter
- K183009 — HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
- K183013 — Vitrea Software Package, VSTP-001A
- K183038 — Corin Optimized Positioning System (OPS) Plan
- K183159 — 3M Clarity Aligners
- K183174 — FlexCath Advance Steerable Sheath and Dilator
- K180430 — Digistat Smart Central
- K180557 — Greene Renal Transplant Stent Set
- K180573 — Responsive Arthroscopy Interference Screw System
- K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
- K180643 — MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
- K181381 — A.B. Dental Devices Dental Implants System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.