FDA 510(k) clearances — page 73
clearances on record, most recent first.
Clearances — page 73
7,201–7,300 of 176,479- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K233605 — ADVIA Centaur EBV-EBNA IgG
- K233606 — ADVIA Centaur EBV-VCA IgM
- K240255 — Electric Wheelchair (JLE-W01A-2023)
- K240330 — HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
- K240605 — Ultra RapidWarm Blast
- K241530 — Stellar Imaging System
- K241644 — SPINEART Navigation Instrument System
- K241685 — SofWave System
- K233920 — EOSedge
- K240796 — myAblation Guide (VB80A)
- K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
- K241708 — Abiomed 14Fr Low Profile Introducer Kit
- K233577 — Sleepio®
- K233653 — Midfield Light Pipe, 23ga (3269.M06-00) +2 more
- K233761 — Orthopaedic Surgery Planning Software (AIJOINT)
- K233992 — Precision AI Surgical Planning System (PAI-SPS)
- K240127 — PlumeSafe X5 Smoke Management System
- K240782 — CellFX Percutaneous Electrode System (SYS3000) +2 more
- K240932 — HybridTherm System
- K240953 — AI Platform 2.0 (AIP002)
- K241360 — Universal Seal (5-12 mm)
- K241635 — da Vinci E-200 Electrosurgical Generator
- K233098 — MYOTouch Muscle Stimulator
- K233534 — Viral Transport Medium
- K233571 — GCI Surgical Gown
- K233601 — Fixone Meniscal Repair
- K233706 — Bendini Cloud Application
- K233798 — Moda-flx Hemodialysis System and Cartridge
- K233984 — Acumen Assisted Fluid Management (AFM) Software Feature
- K240909 — Samsung ECG App v 1.3 (ECG)
- K240981 — Air compression leg massager
- K241181 — Disposable Ureteral Guide Sheath
- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K241311 — Thermoforming Sheet Materials (4 models)
- K241359 — Medline UNITE® MIS Foot Recon Screw System
- K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
- K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)
- K241642 — Diode Laser Hair Removal System (MBT-Diode Laser)
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
- K241892 — Cortera Spinal Fixation System
- K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue Expander
- K241919 — Innovita HCG Pregnancy Rapid Combo Test
- K241970 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
- K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
- K242008 — Coronis OneLook
- DEN230046 — PGDx elio plasma focus Dx
- K232469 — Rüsch Latex Gold Foley Catheter
- K233580 — A Breathing System (ABS)
- K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System
- K233731 — CardIQ Suite
- K233793 — CarboClear® X Pedicle Screw System
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
- K234141 — AISAP Cardio V1.0
- K240035 — TACTIX Vector Syndesmosis System
- K240301 — MammoScreen® (3)
- K240312 — Infinity CentralStation Wide
- K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
- K241105 — 3MP Color LCD Monitor (CL-S301)
- K241137 — Clear Moves Aligner
- K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008
- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
- K241238 — LOOP LED Curing Light System (CLK01)
- K241690 — Logical Liner; World Liner; World Knee Patella
- K241945 — KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
- K242046 — EXULT Knee Replacement System
- K242055 — Freefix Forearm Plating System
- K233541 — ARCHITECT Active-B12 (Holotranscobalamin)
- K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- K233808 — LW Narrow Implant System
- K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- K240898 — SteriTite rigid reusable sterilization container with MediTray Products
- K240967 — ValvuloPro Valvuloplasty Balloon Catheter
- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K241917 — EARP Nerve Cuff Electrode
- K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
- K240280 — Nano-Check RSV Test
- K240446 — Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
- K240531 — SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
- K241539 — Activmotion S
- K241963 — WERAY
- K233723 — Medical surgical mask
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K240326 — Solar Lumbar Interbody Fusion System
- K240359 — PowerGlide Pro Midline Catheter
- K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- K241464 — ARx® SAI Implant System
- K241906 — BioBrace® Reinforced Implant
- K241912 — BIOCHARGE
- K242050 — Montage Settable Bone Putty
- K220328 — EasyStat 300
- K231776 — Cell-Free DNA BCT
- K233287 — Vent Vial Adapter
- K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
- K233530 — EXSYS DEXi (10 models)
- K233725 — Spine Navigation System
- K233994 — VOLT Proximal Humerus 3.5 Plating System
- K234131 — Resolv Endoscopic Hemostat System
- K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
- K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Data sourced from openFDA. This site is unofficial and independent of the FDA.