FDA 510(k) clearances — page 64
clearances on record, most recent first.
Clearances — page 64
6,301–6,400 of 175,620- K241429 — ECHELON Synergy MRI System
- K241547 — Diode Laser Therapy Device (DF-DIODE LASER-S1)
- K241686 — Power wheelchair (N6101)
- K241699 — SUPER VELOCE
- K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K241978 — Shinetell Digital Pregnancy Test
- DEN210037 — SoClean 3+ Bacterial Reduction Device
- K233367 — iDart Lyme IgG ImmunoBlot Kit
- K240868 — Ultravision2 IonPencil
- K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)
- K241365 — Pixie Pulse (SM9068)
- K241402 — Medical Monitor (32HR734S)
- K241656 — Eneka Selectif
- K241846 — E3D-C Interbody System
- K242054 — OptimMRI (v2)
- K242096 — dS FootAnkle Coil 8ch 1.5T
- K222688 — The Trust
- K231950 — MEDIDIODE
- K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
- K233643 — F&P Airvo 3 NIV (PT311US)
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System
- K234053 — F&P Optiflow Flow Diverter
- K240079 — Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)
- K240469 — Access TPO Antibody
- K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K241376 — HyperSuture All Blue Extension Line
- K242016 — EnSite X EP System
- K231775 — GR Resin System MSI
- K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
- K233315 — HipXpert and HipInsight System
- K233356 — Illusion Aligner Pro: Illusion Aligner FLX
- K233702 — SMARxT Tubing and Connectors
- K233720 — Luminopia
- K233822 — i2Contour
- K233844 — OdneClean
- K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- K240229 — Masimo W1
- K240724 — SynthVISION 1.0.0
- K241665 — Omni Legend
- K242009 — 360CAS Knee
- K212969 — Liposaver
- 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); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
- 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); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
- 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 (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
- 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); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.